Grünenthal Clinical Trial Portal
As a research-based pharmaceutical company, Grünenthal recognizes the importance of publicly registering clinical trials and making information including results available. Please consult the table below to easily find information on Grünenthal sponsored clinical trials.
| Number | Product | Condition | Brief Title Column | Phase | Status | Results |
|---|---|---|---|---|---|---|
| No | ||||||
| KF10004/01 | 5% Lidocaine medicated plaster | Postherpetic neuralgia | 3 | Completed | No | |
| KF10004/02 | 5% Lidocaine medicated plaster | Postherpetic neuralgia | 3 | Completed | No | |
| KF10004/10 | 5% Lidocaine medicated plaster | Localized chronic post-operative neuropathic pain | -- | 3 | Completed | Yes |
| EN3324-201 | Axomadol | Moderate to severe chronic low back pain | -- | 2 | Completed | No |
| HP0151Y/09 | Axomadol | -- | A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body | 1 | Completed | No |
| HP0151Y/10 | Axomadol | -- | A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated | 1 | Completed | No |
| HP0151Y/13 | Axomadol | -- | A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure Which Aims to Evaluate Whether GRT0151Y is Likely to be Abused | 1 | Completed | No |
| KF0151Y/06 | Axomadol | Postoperative pain following tonsillectomy | -- | 2 | Completed | Yes |
| KF0151Y/07 | Axomadol | Chronic knee-joint osteoarthritis | -- | 2 | Completed | Yes |
| HP5303/04 | Burprenorphine | -- | Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours | 1 | Completed | No |
| HP5303/05 | Burprenorphine | -- | Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch | 1 | Completed | No |
| KF5303/01 | Burprenorphine | Moderate to severe chronic pain | -- | 3 | Completed | Yes |
| GRT-PK-07 | Cebranopadol | -- | A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol | 1 | Completed | No |
| HP6005/10 | Cebranopadol | -- | A Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users | Completed | No | |
| KF6005/01 | Cebranopadol | Moderate to severe pain following bunionectomy | -- | 2 | Completed | No |
| KF6005/02 | Cebranopadol | Pain due to diabetic polyneuropathy | -- | 2 | Completed | Yes |
| KF6005/03 | Cebranopadol | Moderate to severe pain due to OA of the knee | -- | 2 | Completed | Yes |
| KF6005/04 | Cebranopadol | Moderate to severe pain due to diabetic polyneuropathy | -- | 2 | Completed | Yes |
| KF6005/06 | Cebranopadol | Low back pain | Efficacy and safety of GRT6005 in patients with chronic low back pain | 2 | Completed | Yes |
| KF6005/07 | Cebranopadol | Chronic moderate to severe pain related to cancer | CORAL - Cebranopadol versus morphine prolonged-release in patients with chronic moderate to severe pain related to cancer | 3 | Completed | Yes |
| KF6005/08 | Cebranopadol | Moderate to severe chronic pain due to DPN | Comparison of cebranopadol with placebo and with pregabalin | 2 | Completed | Yes |
| KF6005/09 | Cebranopadol | Chronic moderate to severe pain related to cancer | CORAL XT - Open-label extension trial of the CORAL trial | 3 | Completed | Yes |
| HP8822-01 | Chlormadinone Acetate 2,0mg; Ethynilestradiol 0,02mg | Contraception | Bioavailability of Chlormadinone Acetate/Ethynilestradiol Tablets 2.0 mg/0,02 mg With Regards to Reference Product | 1 | Completed | No |
| HP8810-02 | Clotiazepam 5mg | Treatment of insomnia, anxiety | Bioavailability of Clotiazepam 5 mg With Regards to Reference Product | 1 | Completed | No |
| HP8824-01 | Desogestrel 0,75mg | Contraception | Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product | 1 | Completed | No |
| HP8820-01 | Dienogest 2,0mg | Contraception | Bioavailability of Dienogest 2.0 mg With Regards to Reference Product | 1 | Completed | No |
| HP8811-01 | Dienogest 2,0mg; Ethinylestradiol 0,03mg | Contraception | Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product | 1 | Completed | No |
| HP8825-02 | Duloxetine 60mg | Treatment of depression and anxiety | Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Fasting Conditions | 1 | Completed | No |
| HP8825-01 | Duloxetine 60mg | Treatment of depression and anxiety | Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions | 1 | Completed | No |
| HP9906/06 | Faxeladol | -- | A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it | 1 | Completed | No |
| HP9906/07 | Faxeladol | -- | 1 | Completed | No | |
| KF9906/02 | Faxeladol | Polyneuropathy | -- | 2 | Completed | Yes |
| KF9906/03 | Faxeladol | 2 | Completed | No | ||
| KF6010-02 | GRT6010 | Bladder pain syndrome | -- | 2 | Completed | Yes |
| KF7019-01 | GRT7019 | Chronic pain due to knee osteoarthritis (OA) | Lidocaine/diclofenac epolamine patch (GRT7019) Phase II proof-of-concept trial in subjects with chronic pain due to knee osteoarthritis | 2 | Completed | Yes |
| HP7020-02 | GRT7020 | -- | Safety and tolerability of a dose escalation of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine) for brachial plexus blockade in healthy subjects | 1 | Completed | Yes |
| HP7030-01 | GRT7030 | -- | A comparison of how much oxycodone is in the blood of healthy adults after taking different tablets on a full stomach and on an empty stomach | 1 | Completed | Yes |
| HP7030-03 | GRT7030 | -- | A comparison of how likely it is that different tablets of oxycodone will be broken up and snorted by adults who sometimes take drugs for pleasure | 1 | Completed | No |
| HP8001-01; DCLF/TRMD-GRNN-01 | GRT8001 | -- | Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac | 1 | Completed | Yes |
| KF8001-01 | GRT8001 | Moderate to severe acute pain after third molar extraction | Tramadol/diclofenac fixed-dose combination Phase III trial in acute pain after third molar extraction | 3 | Completed | Yes |
| HP8002-01 | GRT8002 | -- | Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction | 1 | Completed | Yes |
| HP8013-01; PRG-02-GRU/PK-PVR-01 | GRT8013 | -- | Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women | 1 | Completed | No |
| HP8814-01 | levonorgestrel 0,15mg; ethinylestradiol 0,03mg | Contraception | Bioavailability of Levonorgestrel and Ethinyl Estradiol Tablets 15.0 mg/0.03 mg With Regards to Reference Product | 1 | Completed | No |
| HP8814-02 | Levonorgestrol 0,10mg; Ethynilestradiol 0,02mg | Contraception | Bioavailability of Levonorgestrel/Ethinyl Estradiol Tablets 0.1 mg/0.02 mg With Regards to Reference Product | 1 | Completed | No |
| KF10004/03 | Lidocaine | Postherpetic neuralgia and painful diabetic polyneuropathy | -- | 3 | Completed | Yes |
| KF7013-01 | Neridronic Acid | Treatment of pain associated with CRPS-I | Efficacy and safety of intravenous neridronic acid in CRPS-I | 2 | Completed | Yes |
| KF7013-03 | Neridronic Acid | Complex Regional Pain Syndrome (CRPS) | Safety of Intravenous Neridronic Acid in CRPS | 3 | Completed | Yes |
| HP5503-88 | Tapentadol | -- | Comparison of blood concentrations of tapentadol from 4 prolonged release formulations (3 granule formulations and 1 tablet formulation) in healthy adult subjects | 1 | Completed | Yes |
| HP5503-93 | Tapentadol | -- | A comparison of how much tapentadol is in the bloodstream of healthy men after taking different tablets on a full stomach | 1 | Completed | Yes |
| KF5503/12 | Tapentadol | Chronic pain in subjects for whom an opioid treatment is clinically appropriate | -- | 3 | Completed | Yes |
| KF5503/15 | Tapentadol | Moderate to severe chronic malignant tumor-related pain | -- | 3 | Completed | Yes |
| KF5503/35 | Tapentadol | Post-operative pain following abdominal hysterectomy | -- | 3 | Completed | Yes |
| KF5503/37 | Tapentadol | Post-operative pain following bunionectomy | -- | 3 | Completed | Yes |
| KF5503/42 | Tapentadol | Chronic pain due to osteoarthritis of the knee | -- | 3 | Completed | Yes |
| KF5503/44 | Tapentadol | Chronic nociceptive, mixed or neuropathic low back pain | -- | 3 | Completed | Yes |
| KF5503/52 | Tapentadol | Chronic malignant tumor-related pain | Tapentadol in chronic malignant tumor related pain | 3 | Completed | Yes |
| KF5503/53 | Tapentadol | Psychomotor performance as a surrogate parameter for driving ability in subjects with chronic low back pain or osteoarthritis of the knee | -- | 3 | Completed | Yes |
| KF5503/58 | Tapentadol | Severe chronic low back pain with a neuropathic pain component | -- | 3 | Completed | Yes |
| KF5503/60 | Tapentadol | Severe chronic low back pain with a neuropathic pain component | -- | 3 | Completed | Yes |
| KF5503/62 | Tapentadol | Treatment of acute pain following bunionectomy | -- | 2 | Completed | Yes |
| KF5503/65 | Tapentadol | Treatment of acute pain following bunionectomy | A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery | 3 | Completed | Yes |
| KF5503-66 | Tapentadol | -- | A study to look at Tapentadol Tablets in Children and Adolescents in pain | 2 | Completed | Yes |
| KF5503/68 | Tapentadol | Post-surgical pain | -- | 2 | Completed | Yes |
| KF5503-73 | Tapentadol | Moderate to severe acute post-operative pain | Use of intravenous tapentadol solution for injection for pain after surgery in children from newborn to less than 2 years old, including preterm babies | 2 | Completed | Yes |
| KF5503-75 | Tapentadol | Moderate to severe acute pain | A clinical trial to find out how much tapentadol is in the blood of children who take tapentadol every 4 hours to treat short-term pain | 2 | Completed | Yes |
| FO-PK 401 | Tramadol | Children undergoing elective limb surgery or urogenital surgery | -- | 3 | Completed | Yes |
| TRA-RSA-2 | Tramadol | Children undergoing multiple dental extractions under general anaesthesia | -- | 3 | Completed | Yes |
| WIS-AL-TRA86-04-95 | Tramadol | Post-operative pain after abdominal surgery | Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery | 4 | Completed | Yes |
| KF10004/08 | 5% Lidocaine medicated plaster | Localized chronic postoperative neuropathic pain (PoNP) | -- | 2 | Terminated | Yes |
| HP5303/10 | Burprenorphine | -- | Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations | 1 | Terminated | No |
| HP5303/11 | Burprenorphine | -- | -- | 1 | Terminated | No |
| HP5303/12 | Burprenorphine | -- | -- | 1 | Terminated | No |
| HP5303/13 | Burprenorphine | -- | -- | 1 | Terminated | No |
| KF6010/01 | GRT6010 | Peripheral neuropathic pain | -- | 2 | Terminated | Yes |
| HP6015-01 | GRT6015 | -- | Safety, tolerability, pharmacokinetics, and pharmacodynamics of oral single doses of GRT6015 in healthy men | 1 | Terminated | Yes |
| KF7021-04 | GRT7021 | Closure of Surgical Incisions and Lacerations | A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced | Pivotal | Terminated | Yes |
| HP7030-02 | GRT7030 | -- | A comparison of how much oxycodone is in the blood of healthy adults after taking different amounts of different tablets on an empty stomach | 1 | Terminated | No |
| KF7013-02 | Neridronic Acid | Complex Regional Pain Syndrome (CRPS) | Efficacy and safety of intravenous neridronic acid in CRPS | 3 | Terminated | Yes |
| KF7013-04 | Neridronic Acid | Complex Regional Pain Syndrome (CRPS) | Efficacy and safety of intravenous neridronic acid in CRPS | 3 | Terminated | Yes |
| KF5503/16 | Tapentadol | Moderate to severe chronic malignant tumor-related pain | -- | 3 | Terminated | Yes |
| KF5503/43 | Tapentadol | Chronic pain due to osteoarthritis of the knee | -- | 3 | Terminated | Yes |
| KF5503/45 | Tapentadol | Chronic nociceptive, mixed or neuropathic low back pain | -- | 3 | Terminated | Yes |
| KF5503-72 | Tapentadol | Moderate to severe acute post-operative pain | Use of tapentadol oral solution for pain after surgery in children from newborn to less than 2 years old | 2 | Terminated | Yes |
| HP7014-01 | GRT7014 | -- | A comparison of plasma concentrations of hydrocodone and acetaminophen after administration of a new and a marketed tablet formulation under fasted and fed conditions in healthy adults | 1 | Withdrawn | No |
| HP7014-02 | GRT7014 | -- | A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults | 1 | Withdrawn | No |
| HP8010-01; ESTNMG-04-GRU | GRT8010 | -- | Bioequivalence of Two Fixed-dose Combination Tablets Containing Estradiol and Nomegestrol Acetate | 1 | Withdrawn | No |
| HP8012-01 | GRT8012 | -- | A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions | 1 | Withdrawn | No |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF10004/01 |
| Trade Name | Versatis® |
| INN / Sponsor substance code: | 5% Lidocaine medicated plaster |
| Trial title: | A double-blind, multicentre, multiple-dose, enriched enrolment, randomized-withdrawal, parallel-group phase III study with Lido-Patch and corresponding placebo plaster in patients suffering from postherpetic neuralgia (PHN) |
| Brief title: | |
| Trial indication: | Postherpetic neuralgia |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 4/29/2003 |
| Last subject completed: | 6/30/2004 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03745404 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF10004/02 |
| Trade Name | Versatis® |
| INN / Sponsor substance code: | 5% Lidocaine medicated plaster |
| Trial title: | An open-label, multicenter, multiple-dose, Phase III study with Lidocaine 5% medicated plaster in patients suffering from postherpetic neuralgia |
| Brief title: | |
| Trial indication: | Postherpetic neuralgia |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 7/16/2003 |
| Last subject completed: | 7/12/2005 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03765697 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF10004/10 |
| Trade Name | Versatis® |
| INN / Sponsor substance code: | 5% Lidocaine medicated plaster |
| Trial title: | Efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain |
| Brief title: | -- |
| Trial indication: | Localized chronic post-operative neuropathic pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 10/23/2012 |
| Last subject completed: | 6/21/2016 |
| UTN (WHO): | U1111-1143-2130 |
| ClinicalTrials.gov Identifier: | NCT01752322 |
| Eudra CT Identifier: | 2012-000347-28 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP0151Y/09 |
| Trade Name | -- |
| INN / Sponsor substance code: | Axomadol |
| Trial title: | A Phase-I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Escalating Oral Doses of GRT0151Y in Healthy Male and Female Subjects |
| Brief title: | A Clinical Study in Healthy Subjects Which Aims to Investigate the Safety, the Tolerability and the Effects of GRT0151Y and How the Compound is Taken up and Excreted From the Body |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 12/30/2004 |
| Last subject completed: | 7/26/2005 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03761407 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP0151Y/10 |
| Trade Name | -- |
| INN / Sponsor substance code: | Axomadol |
| Trial title: | An Ascending Single-Dose Safety, Tolerability and Exposure Study to Explore the Maximum Tolerated Dose of GRT0151Y in Healthy Adult Non-dependent Recreational Opiate Users |
| Brief title: | A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure to Investigate the Safety and Tolerability of GRT0151Y and to Find Out Which Single Dose of the Compound is Maximally Tolerated |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 1/20/2006 |
| Last subject completed: | 3/2/2006 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03765658 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP0151Y/13 |
| Trade Name | -- |
| INN / Sponsor substance code: | Axomadol |
| Trial title: | A Single-Dose, Randomized, Double Blind, Placebo and Active Controlled Cross-Over Study to Evaluate the Abuse Potential of Three Doses of GRT0151Y in Adult Non-dependent Recreational Opiate Users |
| Brief title: | A Clinical Study in Healthy Adults Who Sometimes Take Drugs for Pleasure Which Aims to Evaluate Whether GRT0151Y is Likely to be Abused |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 6/21/2007 |
| Last subject completed: | 10/25/2007 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03768024 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF0151Y/06 |
| Trade Name | -- |
| INN / Sponsor substance code: | Axomadol |
| Trial title: | A randomized, multi-center, double-blind, parallel-group, multiple-dose study assessing the analgesic efficacy and safety of 3 different doses of GRT0151Y compared to placebo and an active comparator in adults following tonsillectomy |
| Brief title: | -- |
| Trial indication: | Postoperative pain following tonsillectomy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 8/12/2005 |
| Last subject completed: | 2/17/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2005-001656-21 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF0151Y/07 |
| Trade Name | -- |
| INN / Sponsor substance code: | Axomadol |
| Trial title: | A randomized, multi-center, double blind, parallel-group study assessing the analgesic efficacy and safety of different dosages of GRT0151Y BID compared to active comparator BID and placebo BID in subjects with chronic knee-joint osteoarthritis |
| Brief title: | -- |
| Trial indication: | Chronic knee-joint osteoarthritis |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/22/2005 |
| Last subject completed: | 8/11/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2005-003360-26 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/04 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Investigation of the Pharmacokinetics of a Transtec® 35 μg/h Transdermal Patch Application for 96 Hours and a Patch Application for 72 Hours in an Open, Randomised, Single Application, Two-period Crossover, Phase I Study in 30 Healthy Male Volunteers |
| Brief title: | Clinical Study in Healthy Men to Investigate the Uptake of Buprenorphine and Its Elimination From the Body After Dermal Application as Patches for 96 Hours and for 72 Hours |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 4/5/2004 |
| Last subject completed: | 5/26/2004 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03770234 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/05 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Pilot study to investigate the pharmacokinetic characteristics of two buprenorphine transdermal patch formulations as compared to a reference patch |
| Brief title: | Clinical Pilot Study in Healthy Men to Characterize the Uptake of Buprenorphine Into and Its Elimination From the Body After Topical Application of Two New Forms of a Skin Patch in Comparison to a Reference Patch |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 11/7/2005 |
| Last subject completed: | 3/14/2006 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03785613 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5303/01 |
| Trade Name | Transtec® |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | A randomized, 2-arm, parallel group study assessing safety and efficacy of titrated transdermal buprenorphine in patients with moderate to severe chronic non-malignant pain |
| Brief title: | -- |
| Trial indication: | Moderate to severe chronic pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 5/5/2006 |
| Last subject completed: | 8/3/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2005-005365-11 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | GRT-PK-07 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A non-randomized, single-dose, open-label, pharmacokinetic study of cebranopadol in patients with impaired renal function and subjects with normal renal function |
| Brief title: | A Clinical Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of Cebranopadol |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 6/20/2013 |
| Last subject completed: | 9/17/2014 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT03882762 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP6005/10 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A single-dose, nested-randomized, double-blind, double-dummy, placebo- and active-controlled crossover trial to evaluate the abuse potential of 3 doses of GRT6005 in adult non-dependent recreational opioid users |
| Brief title: | A Trial to Evaluate the Abuse Potential of 3 Doses of GRT6005 in Adult Non-dependent Recreational Opioid Users |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 4/15/2013 |
| Last subject completed: | 3/8/2014 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03757559 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/01 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A randomized, Phase IIa trial evaluating the safety and efficacy of a new centrally acting analgesic in subjects with moderate to severe pain following bunionectomy |
| Brief title: | -- |
| Trial indication: | Moderate to severe pain following bunionectomy |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 3/19/2009 |
| Last subject completed: | 10/13/2009 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00872885 |
| Eudra CT Identifier: | -- |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/02 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A randomized Phase IIa trial evaluating the safety and efficacy of a new centrally acting analgesic in subjects with pain due to diabetic polyneuropathy |
| Brief title: | -- |
| Trial indication: | Pain due to diabetic polyneuropathy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 4/15/2009 |
| Last subject completed: | 5/25/2010 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00878293 |
| Eudra CT Identifier: | 2008-004794-18 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/03 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A randomized 4-week Phase IIa trial evaluating the efficacy, safety, and tolerability of GRT6005, a new centrally acting analgesic, in subjects with moderate to severe pain due to osteoarthritis (OA) of the knee |
| Brief title: | -- |
| Trial indication: | Moderate to severe pain due to OA of the knee |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 5/25/2011 |
| Last subject completed: | 12/15/2011 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01357837 |
| Eudra CT Identifier: | 2010-022556-23 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/04 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | A randomized 4-week Phase IIa trial evaluating the efficacy, safety, and tolerability of GRT6005, a new centrally acting analgesic, in subjects with pain due to diabetic polyneuropathy |
| Brief title: | -- |
| Trial indication: | Moderate to severe pain due to diabetic polyneuropathy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 5/4/2011 |
| Last subject completed: | 1/5/2012 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01347671 |
| Eudra CT Identifier: | 2010-022557-42 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/06 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | Efficacy, safety, and tolerability of GRT6005 in subjects with moderate to severe chronic low back pain |
| Brief title: | Efficacy and safety of GRT6005 in patients with chronic low back pain |
| Trial indication: | Low back pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/30/2012 |
| Last subject completed: | 7/10/2014 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01725087 |
| Eudra CT Identifier: | 2012-001920-36 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/07 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | Efficacy, safety, and tolerability of oral cebranopadol versus morphine sulfate PR in subjects with chronic moderate to severe pain related to cancer |
| Brief title: | CORAL - Cebranopadol versus morphine prolonged-release in patients with chronic moderate to severe pain related to cancer |
| Trial indication: | Chronic moderate to severe pain related to cancer |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 30365202 |
| First subject enrolled: | 10/29/2013 |
| Last subject completed: | 10/16/2015 |
| UTN (WHO): | U1111-1143-1808 |
| ClinicalTrials.gov Identifier: | NCT01964378 |
| Eudra CT Identifier: | 2012-001316-35 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/08 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | Efficacy, safety and tolerability of multiple doses of oral cebranopadol in subjects with moderate to severe chronic pain due to diabetic peripheral neuropathy |
| Brief title: | Comparison of cebranopadol with placebo and with pregabalin |
| Trial indication: | Moderate to severe chronic pain due to DPN |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 9/27/2013 |
| Last subject completed: | 1/28/2015 |
| UTN (WHO): | U1111-1151-4331 |
| ClinicalTrials.gov Identifier: | NCT01939366 |
| Eudra CT Identifier: | 2013-000473-68 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6005/09 |
| Trade Name | -- |
| INN / Sponsor substance code: | Cebranopadol |
| Trial title: | An open-label, multi-site trial to describe the safety and tolerability of oral cebranopadol administered for 26 weeks in subjects with cancer-related pain who have completed treatment in the KF6005/07 trial |
| Brief title: | CORAL XT - Open-label extension trial of the CORAL trial |
| Trial indication: | Chronic moderate to severe pain related to cancer |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 12/18/2013 |
| Last subject completed: | 5/3/2016 |
| UTN (WHO): | U1111-1144-0778 |
| ClinicalTrials.gov Identifier: | NCT02031432 |
| Eudra CT Identifier: | 2013-001877-26 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP9906/06 |
| Trade Name | -- |
| INN / Sponsor substance code: | Faxeladol |
| Trial title: | Phase I, Single-center Study to Explore the Relative Bioavailability and the Effect of Food on the Bioavailability of Prolonged Release Tablets Compared to Immediate Release Capsules Each Containing 60 mg of GRTA9906 in 20 Healthy Female Volunteers |
| Brief title: | A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 10/22/2003 |
| Last subject completed: | 12/11/2003 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03765801 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP9906/07 |
| Trade Name | -- |
| INN / Sponsor substance code: | Faxeladol |
| Trial title: | A phase I, single center, multiple dose, dose escalation study (within dose-group randomized, double-blind, placebo-controlled, 2-way cross-over) to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GRT9906 prolonged release tablets in healthy male and female subjects |
| Brief title: | |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 9/15/2004 |
| Last subject completed: | 3/23/2005 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03776110 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF9906/02 |
| Trade Name | -- |
| INN / Sponsor substance code: | Faxeladol |
| Trial title: | Crossover multiple-dose trial assessing the analgesic efficacy and safety of oral GRT9906 PR compared with active comparator and placebo in subjects with painful polyneuropathy of mixed origin |
| Brief title: | -- |
| Trial indication: | Polyneuropathy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/8/2005 |
| Last subject completed: | 8/9/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2005-001404-40 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF9906/03 |
| Trade Name | -- |
| INN / Sponsor substance code: | Faxeladol |
| Trial title: | Crossover multiple-dose trial assessing the analgesic efficacy and safety of oral GRT9906 compared to placebo in subjects with primary fibromyalgia syndrome |
| Brief title: | |
| Trial indication: | |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 9/19/2005 |
| Last subject completed: | 10/20/2006 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03783910 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6010-02 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT6010 |
| Trial title: | Exploratory, randomized, double-blind, placebo-controlled evaluation of efficacy, tolerability, and safety of intravesical instillation of GRT6010 compared to placebo in subjects with bladder pain syndrome |
| Brief title: | -- |
| Trial indication: | Bladder pain syndrome |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 7/26/2017 |
| Last subject completed: | 5/2/2018 |
| UTN (WHO): | U1111-1188-0214 |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2016-003940-35 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7019-01 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT7019 |
| Trial title: | An exploratory, randomized, double-blind, double-dummy, placebo- and active-controlled Phase II trial to evaluate the efficacy and safety of a topical application of GRT7019 in subjects with chronic pain due to knee osteoarthritis |
| Brief title: | Lidocaine/diclofenac epolamine patch (GRT7019) Phase II proof-of-concept trial in subjects with chronic pain due to knee osteoarthritis |
| Trial indication: | Chronic pain due to knee osteoarthritis (OA) |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 6/12/2017 |
| Last subject completed: | 1/17/2018 |
| UTN (WHO): | U1111-1184-3912 |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2016‐002611‐18 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP7020-02 |
| Trade Name | GRT7020 |
| INN / Sponsor substance code: | GRT7020 |
| Trial title: | An exploratory Phase I randomized, single-site, double-blind, active-controlled, parallel-group, single-administration, dose-escalation trial to investigate the safety and tolerability of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine), in perineural administrations for brachial plexus blockade in healthy subjects. |
| Brief title: | Safety and tolerability of a dose escalation of neosaxitoxin alone and in combination with bupivacaine (with and without epinephrine) for brachial plexus blockade in healthy subjects |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 1/30/2018 |
| Last subject completed: | 9/21/2018 |
| UTN (WHO): | U1111-1189-1950 |
| ClinicalTrials.gov Identifier: | NCT03399435 |
| Eudra CT Identifier: | 2016-003958-33 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP7030-03 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT7030 |
| Trial title: | A single-site, randomized, double-blind, double-dummy, active-comparator, placebo-controlled, 3-way crossover trial in adult non-dependent recreational opioid users to compare the intranasal abuse potential of immediate release abuse-deterrent and standard formulations of oxycodone |
| Brief title: | A comparison of how likely it is that different tablets of oxycodone will be broken up and snorted by adults who sometimes take drugs for pleasure |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 7/24/2018 |
| Last subject completed: | 11/20/2018 |
| UTN (WHO): | U1111-1203-4920 |
| ClinicalTrials.gov Identifier: | NCT03765346 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP8001-01; DCLF/TRMD-GRNN-01 |
| Trade Name | Adorlan® |
| INN / Sponsor substance code: | GRT8001 |
| Trial title: | Study of Non-pharmacokinetic Interaction Between Diclofenac 25 mg and 25 mg Tramadol With the Fixed-dose Combination Tablets of the Two Drugs Administered to Healthy Subjects of Both Genders in Fasting State |
| Brief title: | Pharmacokinetic Non-interaction Study With a Fixed-dose Combination Tablet With Tramadol and Diclofenac |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 6/7/2015 |
| Last subject completed: | 6/23/2015 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT03766984 |
| Eudra CT Identifier: | -- |
| Other: | Mexico’s National Registry of Clinical Trials (RNEC) |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal Colombiana S.A. |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF8001-01 |
| Trade Name | Adorlan®, Adorlan Forte® |
| INN / Sponsor substance code: | GRT8001 |
| Trial title: | A randomized, double-blind, multi-site, comparator-controlled, Phase III trial to evaluate the efficacy and safety of a fixed-dose combination of tramadol hydrochloride and diclofenac sodium in acute moderate to severe pain after third molar extraction |
| Brief title: | Tramadol/diclofenac fixed-dose combination Phase III trial in acute pain after third molar extraction |
| Trial indication: | Moderate to severe acute pain after third molar extraction |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 8/26/2017 |
| Last subject completed: | 3/22/2018 |
| UTN (WHO): | U1111-1179-2333 |
| ClinicalTrials.gov Identifier: | NCT03714672 |
| Eudra CT Identifier: | -- |
| Other: | Mexico’s National Registry of Clinical Trials (RNEC) |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal S.A. |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP8002-01 |
| Trade Name | Tradol® |
| INN / Sponsor substance code: | GRT8002 |
| Trial title: | Single Site Pharmacokinetic Non-interaction Study With Open-label, Randomized, Single-dose, Three-period, Six-sequence, Crossover Design to Compare Tramadol Hydrochloride 25 mg Capsules (Tradol [Trade Mark], Product of Grünenthal Mexico S.A. de C.V.) and Ketorolac Tromethamine 10 mg Tablets (Dolac [Trade Mark], Product of Siegfried Rhein, S.A. de C.V.) Administered Separately and Simultaneously in Healthy Volunteers Under Fasting Conditions<br /> |
| Brief title: | Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 6/5/2017 |
| Last subject completed: | 6/30/2017 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT03767036 |
| Eudra CT Identifier: | -- |
| Other: | Mexico’s National Registry of Clinical Trials (RNEC) |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal S.A. |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP8013-01; PRG-02-GRU/PK-PVR-01 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT8013 |
| Trial title: | Open-label, Randomized, Clinical Trial With Three Groups for the Characterization of Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women |
| Brief title: | Characterization of the Pharmacokinetics of a Vaginal Ring With 2.0 g Progesterone in Post-menopausal Women |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | |
| Last subject completed: | |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03737656 |
| Eudra CT Identifier: | -- |
| Other: | Mexico’s National Registry of Clinical Trials (RNEC) |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal S.A. |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF10004/03 |
| Trade Name | Versatis® |
| INN / Sponsor substance code: | Lidocaine |
| Trial title: | Safety and efficacy of lidocaine 5% medicated plaster in comparison with pregabalin in postherpetic neuralgia and diabetic polyneuropathic pain |
| Brief title: | -- |
| Trial indication: | Postherpetic neuralgia and painful diabetic polyneuropathy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 19485723, 19480610, 19301937 |
| First subject enrolled: | 1/4/2007 |
| Last subject completed: | 1/14/2008 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00414349 |
| Eudra CT Identifier: | 2006-003132-29 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7013-01 |
| Trade Name | -- |
| INN / Sponsor substance code: | Neridronic Acid |
| Trial title: | A randomized, double-blind trial investigating the efficacy and safety of intravenous neridronic acid in subjects with complex regional pain syndrome type I (CRPS-I) |
| Brief title: | Efficacy and safety of intravenous neridronic acid in CRPS-I |
| Trial indication: | Treatment of pain associated with CRPS-I |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 4/1/2015 |
| Last subject completed: | 11/2/2016 |
| UTN (WHO): | U1111-1151-2181 |
| ClinicalTrials.gov Identifier: | NCT02402530 |
| Eudra CT Identifier: | 2014-001915-37 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7013-03 |
| Trade Name | -- |
| INN / Sponsor substance code: | Neridronic Acid |
| Trial title: | Open-label Safety Trial of Intravenous Neridronic Acid in Subjects With Complex Regional Pain Syndrome (CRPS) |
| Brief title: | Safety of Intravenous Neridronic Acid in CRPS |
| Trial indication: | Complex Regional Pain Syndrome (CRPS) |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 12/20/2016 |
| Last subject completed: | 1/9/2019 |
| UTN (WHO): | U1111-1180-8099 |
| ClinicalTrials.gov Identifier: | NCT02972359 |
| Eudra CT Identifier: | 2016-001164-11 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5503-88 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Relative bioavailability trial to investigate the pharmacokinetics of tapentadol following the administration of 3 prototype tapentadol 25 mg prolonged release (PR) granule formulations compared to a Palexia® PR 25 mg tablet in healthy adult subjects |
| Brief title: | Comparison of blood concentrations of tapentadol from 4 prolonged release formulations (3 granule formulations and 1 tablet formulation) in healthy adult subjects |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 1/27/2015 |
| Last subject completed: | 6/15/2015 |
| UTN (WHO): | U1111-1159-4436 |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2012-005499-33 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/12 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A randomized double-blind, placebo- and active-control, parallel-arm, Phase 3 study with controlled adjustment of dose to evaluate the efficacy and safety of tapentadol extended-release (ER) in subjects with moderate to severe chronic pain due to osteoarthritis of the knee |
| Brief title: | -- |
| Trial indication: | Chronic pain in subjects for whom an opioid treatment is clinically appropriate |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 28537501, 24985410, 24916058, 24353047, 23709304, 23340531 |
| First subject enrolled: | 6/4/2007 |
| Last subject completed: | 7/18/2008 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00486811 |
| Eudra CT Identifier: | 2006-005783-67 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/15 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A randomized withdrawal, active- and placebo-controlled, double-blind, multi-center Phase III trial assessing safety and efficacy of oral tapentadol PR in subjects with moderate to severe chronic malignant tumor-related pain |
| Brief title: | -- |
| Trial indication: | Moderate to severe chronic malignant tumor-related pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 25054392 |
| First subject enrolled: | 6/13/2007 |
| Last subject completed: | 6/4/2012 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00472303 |
| Eudra CT Identifier: | 2006-004997-28 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/35 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A randomized, double-blind, parallel-arm, placebo- and comparator-controlled trial of the efficacy and safety of multiple doses of immediate-release (IR) CG5503 for post-operative pain following abdominal hysterectomy |
| Brief title: | -- |
| Trial indication: | Post-operative pain following abdominal hysterectomy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 5/19/2007 |
| Last subject completed: | 3/11/2008 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00478023 |
| Eudra CT Identifier: | 2006-004998-95 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/37 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A randomized, double-blind, parallel-group, multi-center, active- and placebo-controlled trial to evaluate the analgesic efficacy and safety of multiple doses of CG5503 IR for postoperative pain following bunionectomy |
| Brief title: | -- |
| Trial indication: | Post-operative pain following bunionectomy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 9/4/2007 |
| Last subject completed: | 12/11/2007 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00609466 |
| Eudra CT Identifier: | -- |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/42 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic pain due to osteoarthritis of the knee taking either WHO Step I or Step II analgesics or no regular analgesics |
| Brief title: | -- |
| Trial indication: | Chronic pain due to osteoarthritis of the knee |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 22792000 |
| First subject enrolled: | 9/21/2009 |
| Last subject completed: | 9/2/2010 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00983073 |
| Eudra CT Identifier: | 2009-010423-58 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/44 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with uncontrolled severe chronic nociceptive, mixed or neuropathic low back pain taking either WHO Step I or Step II analgesics or no regular analgesics |
| Brief title: | -- |
| Trial indication: | Chronic nociceptive, mixed or neuropathic low back pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 22443293 |
| First subject enrolled: | 9/30/2009 |
| Last subject completed: | 7/6/2010 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00983385 |
| Eudra CT Identifier: | 2009-010427-12 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/52 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Open-label, single-arm, flexible dosing, Phase III trial, with oral tapentadol PR in subjects with chronic malignant tumor-related pain who have completed the Maintenance Period of the KF5503/15 trial |
| Brief title: | Tapentadol in chronic malignant tumor related pain |
| Trial indication: | Chronic malignant tumor-related pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 3/3/2011 |
| Last subject completed: | 5/8/2014 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01264887 |
| Eudra CT Identifier: | 2009-013291-46 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/53 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A multicenter, open-label trial to assess cognitive and psychomotor performance as surrogate parameters for driving ability under stable long-term treatment with tapentadol hydrochloride prolonged release tablets in subjects with chronic low back pain or osteoarthritis of the knee |
| Brief title: | -- |
| Trial indication: | Psychomotor performance as a surrogate parameter for driving ability in subjects with chronic low back pain or osteoarthritis of the knee |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 25135385 |
| First subject enrolled: | 2/26/2010 |
| Last subject completed: | 9/3/2010 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2009-015397-35 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/58 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus a combination of tapentadol PR and pregabalin in subjects with severe chronic low back pain with a neuropathic pain component |
| Brief title: | -- |
| Trial indication: | Severe chronic low back pain with a neuropathic pain component |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 24738609, 24750558 |
| First subject enrolled: | 3/23/2011 |
| Last subject completed: | 1/17/2012 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01352741 |
| Eudra CT Identifier: | 2010-019998-14 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/60 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Evaluation of the effectiveness, safety, and tolerability of tapentadol PR versus oxycodone/naloxone PR in non-opioid pre-treated subjects with uncontrolled severe chronic low back pain with a neuropathic pain component |
| Brief title: | -- |
| Trial indication: | Severe chronic low back pain with a neuropathic pain component |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 3/22/2013 |
| Last subject completed: | 1/28/2014 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01838616 |
| Eudra CT Identifier: | 2012-002943-11 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/62 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | A randomized, double-blind, placebo-controlled parallel-group, multicenter trial to evaluate the efficacy and safety of multiple dose administration of an intravenous formulation of tapentadol in the treatment of acute pain following bunionectomy |
| Brief title: | -- |
| Trial indication: | Treatment of acute pain following bunionectomy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 9/26/2011 |
| Last subject completed: | 2/14/2012 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01435577 |
| Eudra CT Identifier: | -- |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/65 |
| Trade Name | -- |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An evaluation of the efficacy and safety of tapentadol oral solution in the treatment of post-operative acute pain requiring opioid treatment in pediatric subjects aged from birth to less than 18 years old |
| Brief title: | A study to look at Tapentadol Oral Solution in Children and Adolescents in pain after Surgery |
| Trial indication: | Treatment of acute pain following bunionectomy |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 2/19/2015 |
| Last subject completed: | 3/14/2019 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT02081391 |
| Eudra CT Identifier: | 2012-004359-35 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503-66 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An open-label trial, enrolling subjects aged 6 years to less than 18 years suffering from pain requiring prolonged release opioid treatment, to evaluate the safety and efficacy of tapentadol PR versus morphine PR, followed by an open-label extension |
| Brief title: | A study to look at Tapentadol Tablets in Children and Adolescents in pain |
| Trial indication: | -- |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 4/29/2015 |
| Last subject completed: | 10/15/2018 |
| UTN (WHO): | U1111-1154-4572 |
| ClinicalTrials.gov Identifier: | NCT02151682 |
| Eudra CT Identifier: | 2012-004360-22 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/68 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Open-label evaluation of the pharmacokinetic profile, safety, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children and adolescents aged from 2 years to less than 18 years |
| Brief title: | -- |
| Trial indication: | Post-surgical pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/15/2012 |
| Last subject completed: | 2/24/2014 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01729728 |
| Eudra CT Identifier: | 2013-002016-27 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503-73 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of intravenous tapentadol solution for injection for the treatment of post-surgical pain in children aged from birth to less than 2 years, including preterm neonates |
| Brief title: | Use of intravenous tapentadol solution for injection for pain after surgery in children from newborn to less than 2 years old, including preterm babies |
| Trial indication: | Moderate to severe acute post-operative pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 4/23/2015 |
| Last subject completed: | 9/27/2018 |
| UTN (WHO): | U1111-1157-3228 |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | 2014-002259-24 |
| Other: | |
| Available for data sharing: | Yes |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503-75 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Open-label investigation of the pharmacokinetic profile, safety, tolerability, and efficacy of multiple administrations of tapentadol oral solution used for treatment of acute pain in children aged 2 years to less than 7 years |
| Brief title: | A clinical trial to find out how much tapentadol is in the blood of children who take tapentadol every 4 hours to treat short-term pain |
| Trial indication: | Moderate to severe acute pain |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 9/9/2019 |
| Last subject completed: | 8/6/2020 |
| UTN (WHO): | U1111-1225-7869 |
| ClinicalTrials.gov Identifier: | |
| Eudra CT Identifier: | 2019-000205-77 |
| Other: | |
| Available for data sharing: | Yes |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | FO-PK 401 |
| Trade Name | Tramal® |
| INN / Sponsor substance code: | Tramadol |
| Trial title: | Serum concentrations of tramadol and its metabolite Ml in children after intravenous or caudal extradural administration of tramadol-HCL |
| Brief title: | -- |
| Trial indication: | Children undergoing elective limb surgery or urogenital surgery |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 3/1/1995 |
| Last subject completed: | 10/31/1995 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | Paediatric studies in scope of Art45 document reference 45000 |
| Other: | EU Article 45 Pediatric database |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | TRA-RSA-2 |
| Trade Name | Tramal® |
| INN / Sponsor substance code: | Tramadol |
| Trial title: | The assessment of the safety and efficacy of tramadol suppositories compared to paracetamol suppositories when administered as premedication together with midazolam in subjects aged 3 to 7 years |
| Brief title: | -- |
| Trial indication: | Children undergoing multiple dental extractions under general anaesthesia |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 7/30/2001 |
| Last subject completed: | 2/28/2003 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | Paediatric studies in scope of Art45 document reference 44997 |
| Other: | EU Article 45 Pediatric database |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | WIS-AL-TRA86-04-95 |
| Trade Name | Tramal® |
| INN / Sponsor substance code: | Tramadol |
| Trial title: | Open clinical study on the analgesic efficacy and safety of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery |
| Brief title: | Open clinical study on the analgesic efficacy of tramadol (TRAMAL) in children with post-operative pain after abdominal surgery |
| Trial indication: | Post-operative pain after abdominal surgery |
| Trial status: | Completed |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 10/23/1995 |
| Last subject completed: | 3/29/1996 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | -- |
| Eudra CT Identifier: | Paediatric studies in scope of Art45 document reference 45006 |
| Other: | EU Article 45 Pediatric database. |
| Available for data sharing: | No |
| Trial phase: | 4 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF10004/08 |
| Trade Name | Versatis® |
| INN / Sponsor substance code: | 5% Lidocaine medicated plaster |
| Trial title: | Lidocaine 5% medicated plaster for the topical treatment of localized chronic postoperative neuropathic pain |
| Brief title: | -- |
| Trial indication: | Localized chronic postoperative neuropathic pain (PoNP) |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 8/24/2010 |
| Last subject completed: | 11/27/2012 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01155986 |
| Eudra CT Identifier: | 2009-016337-10 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/10 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Multiple dose bioequivalence trial comparing a new analgesic transdermal patch formulation to an analgesic patch |
| Brief title: | Multiple Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations |
| Trial indication: | -- |
| Trial status: | Terminated |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 10/10/2006 |
| Last subject completed: | 12/20/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00387777 |
| Eudra CT Identifier: | 2006-003177-27 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/11 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Single dose bioequivalence trial comparing a new analgesic transdermal patch formulation to an analgesic reference patch |
| Brief title: | -- |
| Trial indication: | -- |
| Trial status: | Terminated |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/6/2006 |
| Last subject completed: | 12/14/2006 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00388219 |
| Eudra CT Identifier: | 2006-003178-90 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/12 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Multiple dose bioequivalence trial comparing a down-scaled new analgesic transdermal patch formulation to an analgesic reference patch |
| Brief title: | -- |
| Trial indication: | -- |
| Trial status: | Terminated |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 5/21/2007 |
| Last subject completed: | 9/4/2007 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00469053 |
| Eudra CT Identifier: | 2007-000667-22 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP5303/13 |
| Trade Name | -- |
| INN / Sponsor substance code: | Burprenorphine |
| Trial title: | Single dose bioequivalence trial comparing a down-scaled new analgesic transdermal patch formulation to an analgesic reference patch |
| Brief title: | -- |
| Trial indication: | -- |
| Trial status: | Terminated |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 5/29/2007 |
| Last subject completed: | 8/10/2007 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00469404 |
| Eudra CT Identifier: | 2007-000668-26 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF6010/01 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT6010 |
| Trial title: | Evaluation of the efficacy, tolerability, and safety of 7 days of treatment with GRT6010 or pregabalin in comparison to placebo in subjects with peripheral neuropathic pain |
| Brief title: | -- |
| Trial indication: | Peripheral neuropathic pain |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 2/23/2012 |
| Last subject completed: | 1/18/2013 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT01485094 |
| Eudra CT Identifier: | 2011-002092-42 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7021-04 |
| Trade Name | GRT7021 |
| INN / Sponsor substance code: | GRT7021 |
| Trial title: | A Randomized, Open-label, Multi-center, Controlled Clinical Study to Compare MAR-CUTIS with Dermabond Advanced in Closure of Surgical Incisions and Lacerations up to 15cm |
| Brief title: | A Clinical Study to Compare MAR-CUTIS With Dermabond Advanced |
| Trial indication: | Closure of Surgical Incisions and Lacerations |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 10/30/2018 |
| Last subject completed: | 9/4/2019 |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03688880 |
| Eudra CT Identifier: | |
| Other: | CUTIS topical skin adhesive – learn more about CUTIS |
| Available for data sharing: | No |
| Trial phase: | Pivotal |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7013-02 |
| Trade Name | -- |
| INN / Sponsor substance code: | Neridronic Acid |
| Trial title: | Randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of intravenous neridronic acid in subjects with complex regional pain syndrome (CRPS) |
| Brief title: | Efficacy and safety of intravenous neridronic acid in CRPS |
| Trial indication: | Complex Regional Pain Syndrome (CRPS) |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 5/30/2018 |
| Last subject completed: | 7/31/2019 |
| UTN (WHO): | U1111-1187-8036 |
| ClinicalTrials.gov Identifier: | NCT03530345 |
| Eudra CT Identifier: | 2016-003833-91 |
| Other: | Australien New Zealand Clinical Trials Registry (ANZCTR) |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF7013-04 |
| Trade Name | -- |
| INN / Sponsor substance code: | Neridronic Acid |
| Trial title: | Placebo-controlled efficacy and safety trial of intravenous neridronic acid in subjects with complex regional pain syndrome (CRPS) |
| Brief title: | Efficacy and safety of intravenous neridronic acid in CRPS |
| Trial indication: | Complex Regional Pain Syndrome (CRPS) |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | 5/31/2018 |
| Last subject completed: | 8/1/2019 |
| UTN (WHO): | U1111-1203-5020 |
| ClinicalTrials.gov Identifier: | NCT03560986 |
| Eudra CT Identifier: | 2017-004244-37 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/16 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | <p>A randomized withdrawal, active- and placebo-controlled, doubleblind, multi-center Phase III trial assessing safety and efficacy of oral tapentadol PR(a) in subjects with moderate to severe chronic malignant tumor-related pain</p> <p>(a) PR means Prolonged Release and is the recommended nomenclature for use in Europe. ER means Extended Release and is the recommended nomenclature for use in the United States. “PR” is synonymous with “ER” and is interchangeable in the report</p> |
| Brief title: | -- |
| Trial indication: | Moderate to severe chronic malignant tumor-related pain |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 6/29/2007 |
| Last subject completed: | 2/2/2009 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00505414 |
| Eudra CT Identifier: | 2007-001985-34 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/43 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic pain due to osteoarthritis of the knee taking WHO Step III analgesics but showing a lack of tolerability |
| Brief title: | -- |
| Trial indication: | Chronic pain due to osteoarthritis of the knee |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 23912473 |
| First subject enrolled: | 10/2/2009 |
| Last subject completed: | 8/12/2010 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00982280 |
| Eudra CT Identifier: | 2009-010425-39 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503/45 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | An evaluation of the effectiveness and tolerability of tapentadol hydrochloride prolonged release, and tapentadol hydrochloride immediate release on demand, in subjects with severe chronic nociceptive, mixed or neuropathic low back pain taking WHO Step III analgesics but showing a lack of tolerability |
| Brief title: | -- |
| Trial indication: | Chronic nociceptive, mixed or neuropathic low back pain |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | 23475406 |
| First subject enrolled: | 10/30/2009 |
| Last subject completed: | 1/21/2011 |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT00986258 |
| Eudra CT Identifier: | 2009-010428-25 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 3 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | KF5503-72 |
| Trade Name | Palexia®, Nucynta®, Yantil® |
| INN / Sponsor substance code: | Tapentadol |
| Trial title: | Open-label evaluation of the population pharmacokinetic profile, safety, tolerability, and efficacy of tapentadol oral solution for the treatment of post-surgical pain in children aged from birth to less than 2 years. |
| Brief title: | Use of tapentadol oral solution for pain after surgery in children from newborn to less than 2 years old |
| Trial indication: | Moderate to severe acute post-operative pain |
| Trial status: | Terminated |
| Results posted: | Yes |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | 11/5/2014 |
| Last subject completed: | 11/3/2016 |
| UTN (WHO): | U1111-1153-1662 |
| ClinicalTrials.gov Identifier: | NCT02221674 |
| Eudra CT Identifier: | 2014-000623-24 |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 2 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP7014-01 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT7014 |
| Trial title: | A relative bioavailability trial to investigate the pharmacokinetics of two immediate release fixed dose combinations of hydrocodone bitartrate and acetaminophen (a new abuse deterrent tablet and a marketed tablet) administered under fasted and fed conditions in healthy male and female adult subjects |
| Brief title: | A comparison of plasma concentrations of hydrocodone and acetaminophen after administration of a new and a marketed tablet formulation under fasted and fed conditions in healthy adults |
| Trial indication: | -- |
| Trial status: | Withdrawn |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | |
| Last subject completed: | |
| UTN (WHO): | U1111-1183-5343 |
| ClinicalTrials.gov Identifier: | NCT03137017 |
| Eudra CT Identifier: | -- |
| Other: | -- |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP7014-02 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT7014 |
| Trial title: | A Relative Bioavailability Trial to Investigate the Pharmacokinetics of Different Amounts of Tablets of Two Immediate Release Fixed Dose Combinations of Hydrocodone Bitartrate 5 mg/Acetaminophen 325 mg (a New Abuse Deterrent Tablet and a Marketed Tablet) Under Fasted Conditions in Healthy Male and Female Adult Subjects |
| Brief title: | A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults |
| Trial indication: | -- |
| Trial status: | Withdrawn |
| Results posted: | No |
| PubMed unique identifier [PMID]: | -- |
| First subject enrolled: | |
| Last subject completed: | |
| UTN (WHO): | U1111-1184-8922 |
| ClinicalTrials.gov Identifier: | NCT03137030 |
| Eudra CT Identifier: | -- |
| Other: | -- |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal GmbH |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP8010-01; ESTNMG-04-GRU |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT8010 |
| Trial title: | Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Single-dose Trial to Investigate the Bioequivalence of Two Oral Formulations of a Fixed-dose Combination Tablet Containing 1.5 mg Estradiol and 2.5 mg Nomegestrol Acetate (Product of Laboratorios Andromaco S.A. [Test Product] Versus Stezza, Product of Merck Sharp and Dohme Farmaceutica Ltda. [Reference Product]) in Postmenopausal Women Under Fasting Conditions |
| Brief title: | Bioequivalence of Two Fixed-dose Combination Tablets Containing Estradiol and Nomegestrol Acetate |
| Trial indication: | -- |
| Trial status: | Withdrawn |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | |
| Last subject completed: | |
| UTN (WHO): | -- |
| ClinicalTrials.gov Identifier: | NCT03749733 |
| Eudra CT Identifier: | -- |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal S.A. |
| Trial documents: |
| Key Column Headline | Value Column Headline |
|---|---|
| Trial Identifier (Sponsor): | HP8012-01 |
| Trade Name | -- |
| INN / Sponsor substance code: | GRT8012 |
| Trial title: | Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Trial to Evaluate the Bioequivalence of Two Delayedrelease Oral Formulations of a Fixed Combination of Doxylamine Succinate 10 mg/Pyridoxine Hydrochloride 10 mg (Test Product: Product of Tecnandina, S.A. TENSA; Reference Product: Diclegis (Registered Trademark) Product of Duchesnay Inc.) After a Single Administration of Two Tablets to Healthy Women Under Fasting Conditions |
| Brief title: | A Study to Investigate Differences in the Extent and Rate of Absorption of Doxylamine/Pyridoxine From 2 Different Products Under Fasting Conditions |
| Trial indication: | -- |
| Trial status: | Withdrawn |
| Results posted: | No |
| PubMed unique identifier [PMID]: | |
| First subject enrolled: | |
| Last subject completed: | |
| UTN (WHO): | |
| ClinicalTrials.gov Identifier: | NCT03905564 |
| Eudra CT Identifier: | |
| Other: | |
| Available for data sharing: | No |
| Trial phase: | 1 |
| Trial sponsor: | Grünenthal, S.A. |
| Trial documents: |