43 completed, 8 terminated, 1 active not recruiting, 1 unknown. 23 Phase 3, 12 Phase 2, 8 Phase 1, 7 Phase 4, 3 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 23 | Completed 18, Terminated 5 |
| Phase 2 | 12 | Completed 11, Terminated 1 |
| Phase 1 | 8 | Completed 7, Terminated 1 |
| Phase 4 | 7 | Completed 5, Terminated 1, Unknown 1 |
| Not applicable | 3 | Completed 3 |
Follow Tapentadol: new trials by email Literature Review of Tapentadol trials Research Report on Tapentadol
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Tapentadol vs Tramadol in Arthroscopic Rotator Cuff Repair Tramadol, Tapentadol - Arthroscopic Rotator Cuff Repair (ARCR), Postoperative Pain | Active not recruiting | University of Thessaly | 64 | 2026-07-01 | 2026-10-21 | |
| Role of Preoperative Tapentadol in Reduction of Perioperative Analgesic Requirement After Breast Conservative Surgery in Cancer Patients. Tapentadol, Placebo - Breast Cancer | Not applicable | Completed | Shaukat Khanum Memorial Cancer Hospital & Research Centre | 70 | 2024-11-15 | 2026-01-08 |
| Tapentadol vs Pregabalin for Postoperative Pain in Lower Limb Surgery Tapentadol, Pregabalin - Acute Postoperative Pain, Lower Limb Surgery | Not applicable | Completed | ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" | 46 | 2024-06-19 | 2026-05-15 |
| Tapentadol vs Tramadol in Total Knee Arthroplasty Tapentadol, Tramadol - Total Knee Replacement, Post-operative Pain | Phase 4 | Unknown | University of Thessaly | 96 | 2023-05-01 | 2024-05-14 |
| Comparison of Postoperative Analgesia Between Intravenous Paracetamol and Intranasal Tapentadol Tapentadol Hydrochloride - Lower Limb Fracture | Phase 4 | Completed | Kempegowda Institute of Medical Sciences, Bangalore | 74 | 2021-07-05 | 2023-08-21 |
| Safety and Efficacy of Pre-emptive Tapentadol vs Pregabalin in Post Operative Pain Following Surgery Tapentadol 100 MG Oral Tablet, Pregabalin 150mg - Osteoarthritis, Knee | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | 95 | 2018-08-01 | 2020-06-25 |
| Effects of Tapentadol Versus Oxycodone After Hysterectomy. Tapentadol, Oxycodone - Pain, Postoperative, Pain Uterus | Phase 4 | Completed | Oslo University Hospital | 86 | 2017-12-04 | 2019-04-04 |
| Preemptive Tapentadol on Post-operative Analgesia Following Total Knee Arthroplasty Tapentadol 100 MG, Placebo Oral Tablet - Analgesia | Not applicable | Completed | All India Institute of Medical Sciences, Bhubaneswar | 90 | 2017-11-01 | 2018-09-10 |
| Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo Tapentadol, Oxycodone, Placebo - Joint Diseases | Phase 3 | Completed | St. Olavs Hospital | 134 | 2015-09-01 | 2021-11-16 |
| Opioid Induced Gait Variability Tapentadol 50 mg Oral Tablet, Tramadol Hydrochloride 100 mg Extended Release Oral Tablet, Placebo Oral Tablet - Opioid Induced Motor Disturbances | Phase 1 / Phase 2 | Completed | Frederiksberg University Hospital | 24 | 2015-05-19 | 2017-11-06 |
| A Study to Look at Tapentadol Tablets in Children and Adolescents in Pain Tapentadol prolonged release, Morphine prolonged release - Pain | Phase 2 / Phase 3 | Completed | Grünenthal GmbH | 73 | 2015-04-29 | 2019-09-12 |
| A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL, Placebo - Acute Pain | Phase 3 | Completed | Grünenthal GmbH | 216 | 2015-02-19 | 2020-01-18 |
| Use of Tapentadol Oral Solution for Pain After Surgery in Children From Newborn to Less Than 2 Years Old Tapentadol - Moderate to Severe Acute Postoperative Pain | Phase 2 | Terminated | Grünenthal GmbH | 40 | 2014-11-05 | 2018-01-29 |
| Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain Morphine, Fentanyl, Methadone - Tumor, Cancer Pain | Completed | Mario Negri Institute for Pharmacological Research | 150 | 2013-09-01 | 2016-04-14 | |
| Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component. Tapentadol Prolonged Release, Oxycodone/Naloxone Prolonged Release - Back Pain, Low Back Pain | Phase 4 | Completed | Grünenthal GmbH | 367 | 2013-04-01 | 2016-02-24 |
| Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain Tapentadol - Postoperative Pain, Acute Pain | Phase 2 | Completed | Grünenthal GmbH | 86 | 2012-11-01 | 2019-11-04 |
| Efficacy and Safety of GRT6005 in Patients With Chronic Low Back Pain. Matching Placebo, Low Dose GRT6005, Medium Dose GRT6005 - Low Back Pain | Phase 2 | Completed | Tris Pharma, Inc. | 1089 | 2012-11-01 | 2021-07-15 |
| Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models Tapentadol immediate release, placebo - Pain, Hyperalgesia | Phase 1 | Terminated | University Hospital Schleswig-Holstein | 24 | 2012-10-01 | 2022-09-14 |
| Tapentadol Versus Oxycodone - a Mechanism-based Treatment Approach in Neuropathic Pain tapentadol, oxycodone - Peripheral Neuropathy | Phase 4 | Terminated | University Hospital Schleswig-Holstein | 3 | 2011-10-01 | 2025-01-07 |
| Pharmacokinetics and Safety Study of Tapentadol for Postsurgical Pain in Children and Adolescents Tapentadol (OS) Oral Solution - Pain, Postoperative, Postoperative Pain | Phase 2 | Completed | Janssen Research & Development, LLC | 45 | 2011-10-01 | 2014-07-14 |
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Pain (22) · Chronic Pain (12) · Low Back Pain (10) · Pain, Postoperative (10) · Agnosia (7) · Osteoarthritis (7) · Acute Pain (6) · Neoplasms (5) · Neuralgia (5) · Arthralgia (4) · Back Pain (4) · Osteoarthritis, Knee (4) · Bunion (2) · Cancer Pain (2) · Constipation (2)
Grünenthal GmbH (16) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (16) · Janssen Pharmaceutical K.K. (3) · All India Institute of Medical Sciences, Bhubaneswar (2) · Janssen Research & Development, LLC (2) · University Hospital Schleswig-Holstein (2) · University of Thessaly (2) · Frederiksberg University Hospital (1) · ISSSTE Hospital Regional "Gral. Ignacio Zaragoza" (1) · Kempegowda Institute of Medical Sciences, Bangalore (1) · Mario Negri Institute for Pharmacological Research (1) · Mayo Clinic (1) · Ortho-McNeil Janssen Scientific Affairs, LLC (1) · Oslo University Hospital (1) · Shaukat Khanum Memorial Cancer Hospital & Research Centre (1)
Germany (13) · United States (12) · Spain (11) · Poland (10) · France (8) · United Kingdom (8) · Hungary (6) · Italy (5) · Austria (4) · Belgium (4) · Bulgaria (4) · Canada (4) · Japan (4) · Croatia (3) · Czechia (3)
Eleni Arnaoutolglou, MD, PhD (2) · Metaxia Bareka, MD, PhD (2) · Barbara Hoggart, Dr. MD (1) · Debasish Hota, MD;DM (1) · Dr. Allah Ditta Ashfaq (1) · Hans Georg Kress, Dr. (1) · Hans Kress, Prof. MD (1) · Hans-Georg Kress, Prof. Dr. med (1)
PMID 23340531, PMID 24985410, PMID 23709304, PMID 24353047, PMID 24916058, PMID 11020772, PMID 15596866, PMID 17578977, PMID 18307181, PMID 19302899, PMID 19445652, PMID 20119464, PMID 20602712, PMID 21162697, PMID 21494892, PMID 21712862, PMID 21887117, PMID 22227789, PMID 22443293, PMID 22792000, PMID 23325966, PMID 23475406, PMID 23703422, PMID 23937387, PMID 24436674, PMID 25054392, PMID 25255012, PMID 25759598, PMID 25985806, PMID 26095455, PMID 26428249, PMID 27062079, PMID 27295489, PMID 28432601, PMID 28767611, PMID 29392204, PMID 30649458, PMID 31213888, PMID 32773594, PMID 33428347, PMID 35482392, PMID 8346839
2009 (5), 2014 (1), 2015 (1), UL1RR024150 (1)