22 completed, 2 terminated, 1 unknown. 12 Phase 4, 6 Phase 1, 3 Phase 3, 2 Not applicable, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 4 | 12 | Completed 10, Terminated 2 |
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 3 | Completed 3 |
| Not applicable | 2 | Completed 2 |
| Phase 2 | 1 | Unknown 1 |
Follow Ultracet: new trials by email Literature Review of Ultracet trials Research Report on Ultracet
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 |
|---|---|---|---|---|---|---|
| Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets Ultracet Tablets, Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer) - Healthy | Phase 4 | Completed | Pfizer | 60 | 2019-03-26 | 2019-07-17 |
| TAP Block and Subacute Pain in Inguinal Herniography transversus abdominis plane block, Tramadol and paracetamol - Postoperative Pain | Not applicable | Completed | Istanbul University | 2 | 2016-04-01 | 2019-02-27 |
| A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions CL-108, Vicoprofen, Ultracet - Healthy | Phase 1 | Completed | Charleston Laboratories, Inc | 20 | 2014-11-01 | 2017-05-02 |
| Does Duloxetine Reduce Chronic Pain After Total Knee Arthroplasty? Duloxetine, celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone - Neuropathic Pain | Phase 2 | Unknown | Hanyang University Seoul Hospital | 168 | 2014-08-01 | 2016-02-19 |
| Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION) buprenorphine, tramadol/acetaminophen - Pain | Phase 4 | Completed | Mundipharma Korea Ltd | 136 | 2013-10-01 | 2016-07-11 |
| Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days, Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days - Periapical Abscess | Not applicable | Completed | Federal University of Rio Grande do Sul | 27 | 2013-04-01 | 2016-04-25 |
| Assessment of the Pharmacokinetics of a Sustained Release Formulation of a Tramadol/Acetaminophen Combination Tramadol HCI/Acetaminophen - Pain | Phase 1 | Completed | Yungjin Pharm. Co., Ltd. | 24 | 2012-01-01 | 2021-05-05 |
| A Study Comparing the Effectiveness and Safety of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen With Immediate Release (IR) Tramadol HCl/Acetaminophen in Participants With Moderate to Severe Postoperative Pain Tramadol HCl/Acetaminophen ER, Tramadol HCl/Acetaminophen IR - Pain, Postoperative | Phase 3 | Completed | Janssen Korea, Ltd., Korea | 320 | 2009-11-01 | 2013-06-20 |
| An Efficacy and Safety Study of Tramadol/Acetaminophen Versus Diclofenac in the Treatment of Pain in Participants With Ankylosing Spondylitis Receiving Stable Treatment of Disease Modifying Anti-rheumatic Drugs (DMARDs) Tramadol /acetaminophen, Diclofenac - Spondylitis, Ankylosing, Pain | Phase 4 | Terminated | Johnson & Johnson Taiwan Ltd | 8 | 2008-09-01 | 2026-06-04 |
| A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED) Naproxen, Placebo, Ultracet - Osteoarthritis | Phase 1 | Completed | Merck Sharp & Dohme LLC | 22 | 2008-06-01 | 2015-11-20 |
| A Comparative Bioavailability/Food Effect Study of Immediate-Release and Extended-Release Tramadol HCl/Acetaminophen Combination Products Following Single-Dose and Multiple-Dose Administration in Healthy Adult Volunteers DDS-06C (650 mg acetaminophen and 75 mg tramadol HCl), DDS-06C (650 mg acetaminophen and 75 mg tramadol), Zaldiar® - Healthy | Phase 1 | Completed | Labopharm Inc. | 58 | 2008-05-01 | 2012-04-25 |
| Tramadol/Acetaminophen(Ultracet) AS add-on Therapy in the Treatment of Patients With Ankylosing Spondylitis Ultracet - Ankylosing Spondylitis | Phase 4 | Completed | Chung Shan Medical University | 60 | 2008-03-01 | 2010-04-01 |
| Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery tramacet, naloxone, tramacet, Acetaminophen - Hip Arthroplasty, Knee Arthroplasty | Phase 3 | Completed | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | 45 | 2007-12-17 | 2017-08-28 |
| A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets Tramadol/acetaminophen - Rheumatic Diseases | Completed | Janssen Korea, Ltd., Korea | 982 | 2007-09-01 | 2014-04-28 | |
| Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery tramadol/acetaminophen, acetaminophen - Postoperative Pain | Phase 4 | Completed | The University of Hong Kong | 60 | 2007-04-01 | 2013-02-01 |
| A Study to Compare Safety and Efficacy of Tramadol Hydrochloride/Acetaminophen With Gabapentin in Participants With Diabetic Neuropathy Tramadol hydrochloride/ Acetaminophen, Gabapentin - Diabetic Neuropathy | Phase 4 | Completed | Janssen Korea, Ltd., Korea | 162 | 2006-12-01 | 2013-08-12 |
| An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients tramadol hydrochloride; acetaminophen - Pain | Phase 4 | Completed | Johnson & Johnson Taiwan Ltd | 60 | 2005-12-01 | 2010-04-28 |
| A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis tramadol hydrochloride /acetaminophen, tramadol hydrochloride / acetaminophen and placebo - Osteoarthritis | Phase 4 | Completed | Janssen Korea, Ltd., Korea | 250 | 2005-08-01 | 2010-02-05 |
| A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain tramadol hydrochloride , acetaminophen - Back Pain, Low Back Pain | Phase 4 | Terminated | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 22 | 2005-03-01 | 2011-06-10 |
| A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain Tramadol HCI/acetaminophen - Cancer | Phase 4 | Completed | Janssen-Cilag Ltd.,Thailand | 35 | 2004-07-01 | 2013-10-23 |
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Pain (7) · Pain, Postoperative (4) · Agnosia (2) · Diabetic Neuropathies (2) · Lecithin Cholesterol Acyltransferase Deficiency (2) · Osteoarthritis (2) · Spondylitis, Ankylosing (2) · Arthritis, Rheumatoid (1) · Back Pain (1) · Breakthrough Pain (1) · Cancer Pain (1) · Diabetes Mellitus (1) · Fasting (1) · Low Back Pain (1) · Neoplasms (1)
Janssen Korea, Ltd., Korea (5) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (3) · Johnson & Johnson Taiwan Ltd (2) · Par Pharmaceutical, Inc. (2) · Charleston Laboratories, Inc (1) · Chung Shan Medical University (1) · Federal University of Rio Grande do Sul (1) · Hanyang University Seoul Hospital (1) · Istanbul University (1) · Janssen-Cilag Ltd.,Thailand (1) · Labopharm Inc. (1) · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (1) · Merck Sharp & Dohme LLC (1) · Mundipharma Korea Ltd (1) · Pfizer (1)
South Korea (2) · Taiwan (2) · Brazil (1) · Canada (1) · Hong Kong (1) · Thailand (1) · United Kingdom (1)
Ralph Scallion (2) · Choonghyeok Choi (1) · Darren Wilbraham (1) · Jinhyok Kim, Dr.PhD (1) · Ngozi Imasogie, MBBS, FRCA UK (1)
PMID 15157685, PMID 17257476, PMID 20175977, PMID 25299350, PMID 25618318, PMID 29056859