22 completed, 7 terminated, 2 unknown. 20 Phase 3, 6 Phase 4, 5 Phase 2, 2 Not applicable, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 15, Terminated 3, Unknown 2 |
| Phase 4 | 6 | Completed 3, Terminated 3 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Not applicable | 2 | Completed 2 |
| Phase 1 | 1 | Terminated 1 |
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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 |
|---|---|---|---|---|---|---|
| Rofecoxib Efficacy and Safety Evaluation Trial in Hemophilic Arthropathy TRM-201 (Rofecoxib), Placebo - Hemophilic Arthropathy | Phase 3 | Terminated | Tremeau Pharmceuticals, Inc. | 2 | 2021-06-02 | 2022-10-27 |
| Selective COX-II Inhibitor as an Adjuvant Therapy in Patients With Resectable Advanced Stomach Cancer ( Histological Staging ≥ T2N1) - A Multi-Centre Prospective Randomised Controlled Trial Oral Vioxx (Rofecoxib) - Cancer of Stomach | Phase 3 | Unknown | Chinese University of Hong Kong | 214 | 2004-10-01 | 2005-11-17 |
| Selective COX-II Inhibitor as a Palliative Therapy in Patients With R1 or R2 Resection for Disseminated Stomach Cancer - A Multi-Centre Prospective Randomized Controlled Trial Vioxx (Rofecoxib) - Cancer of Stomach | Phase 3 | Unknown | Chinese University of Hong Kong | 206 | 2004-10-01 | 2005-12-09 |
| An End to the Yom Kippur (and Ramadan) Headache Rofecoxib - Headache | Not applicable | Completed | Sheba Medical Center | 220 | 2004-09-01 | 2006-01-27 |
| A Study of Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement (0966-259) MK0966; rofecoxib, Comparator: diclofenac 2x 75 mg - Pain | Phase 4 | Terminated | Merck Sharp & Dohme LLC | 11 | 2004-05-25 | 2017-05-09 |
| A Study of Rofecoxib Versus Naproxen in the Treatment of Chinese Patient With Rheumatoid Arthritis (0966-231) MK0966; rofecoxib, Comparator: naproxen tablet 500 mg - Rheumatoid Arthritis | Phase 4 | Completed | Merck Sharp & Dohme LLC | 150 | 2004-01-07 | 2017-05-25 |
| Coxib-inhibition of Duodenal Polyp Growth in FAP Rofecoxib, placebo - Duodenal Polyposis | Phase 2 / Phase 3 | Terminated | Oslo University Hospital | 38 | 2003-09-01 | 2011-07-06 |
| A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED) MK0966, rofecoxib, Comparator: diclofenac sodium, placebo - Postoperative Pain | Phase 3 | Completed | Merck Sharp & Dohme LLC | 251 | 2003-09-01 | 2017-05-09 |
| A Double-blind, Double-dummy, Multicenter, Randomized Study of the Efficacy and Tolerability of Valdecoxib 40 mg Versus Rofecoxib 50 mg in Treating the Symptoms of Ankle Sprain valdecoxib, rofecoxib - Acute Pain | Phase 4 | Terminated | Pfizer | 45 | 2003-06-04 | 2018-11-30 |
| A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-219) MK0966, rofecoxib, Comparator: celecoxib, placebo - Osteoarthritis | Phase 3 | Completed | Merck Sharp & Dohme LLC | 395 | 2003-04-29 | 2017-05-09 |
| A Study to Evaluate Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome MK0966; rofecoxib, Comparator: diclofenac, placebo - Pain | Phase 3 | Terminated | Merck Sharp & Dohme LLC | 274 | 2003-04-01 | 2006-12-05 |
| A Study of Two Approved Drugs in Patients With Osteoarthritis (0966-220)(COMPLETED) MK0966, rofecoxib, Comparator: celecoxib, placebo - Osteoarthritis | Phase 3 | Completed | Merck Sharp & Dohme LLC | 413 | 2003-04-01 | 2017-05-09 |
| CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen Celecoxib, Acetaminophen, Rofecoxib - Antiphospholipid Antibody Syndrome | Not applicable | Completed | Hospital Universitario Pedro Ernesto | 22 | 2003-03-01 | 2013-01-08 |
| Treatment With MK0966 for the Prevention of Prostate Cancer (0966-201) rofecoxib, Comparator: placebo (unspecified) - Prostate Cancer | Phase 3 | Completed | Merck Sharp & Dohme LLC | 15000 | 2003-01-08 | 2017-05-09 |
| Study of Rofecoxib and Prolonged Constant Infusion of Gemcitabine in the Polychemotherapy Treatment of Advanced NSCLC gemcitabine, prolonged continuous infusion gemcitabine, cisplatin - Advanced Non-small Cell Lung Cancer | Phase 2 / Phase 3 | Completed | National Cancer Institute, Naples | 400 | 2003-01-01 | 2023-03-23 |
| Rofecoxib and Bupivacaine to Prevent Pain After Third Molar (Wisdom Tooth) Extraction Rofecoxib and Bupivacaine - Pain, Tooth Extraction | Phase 2 | Completed | National Institute of Dental and Craniofacial Research (NIDCR) | 136 | 2002-12-01 | 2008-03-04 |
| A Study of Rofecoxib in Familial Adenomatous Polyposis (FAP) (0966-205)(TERMINATED) MK0966; rofecoxib / Duration of Treatment: 24 weeks, Comparator: placebo / Duration of Treatment: 24 weeks - Adenomatous Polyposis Coli | Phase 4 | Terminated | Merck Sharp & Dohme LLC | 62 | 2002-08-06 | 2019-09-20 |
| A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-190)(COMPLETED) MK0966, rofecoxib, Comparator: valdecoxib, placebo - Postoperative Pain | Phase 3 | Completed | Merck Sharp & Dohme LLC | 125 | 2002-08-01 | 2017-05-09 |
| A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-183) MK0966, rofecoxib, Comparator: oxycodone with acetaminophen, placebo - Postoperative Pain | Phase 3 | Completed | Merck Sharp & Dohme LLC | 269 | 2002-06-01 | 2016-02-22 |
| A Study of Two Approved Drugs in the Treatment of Postoperative Dental Pain (0966-182) MK0966, rofecoxib, Comparator: oxycodone and acetaminophen - Postoperative Pain | Phase 3 | Completed | Merck Sharp & Dohme LLC | 271 | 2002-06-01 | 2015-11-25 |
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Pain (7) · Pain, Postoperative (5) · Osteoarthritis (4) · Hyperalgesia (2) · Stomach Neoplasms (2) · Acute Pain (1) · Adenomatous Polyposis Coli (1) · Alzheimer Disease (1) · Antiphospholipid Syndrome (1) · Arthralgia (1) · Arthritis, Rheumatoid (1) · Barrett Esophagus (1) · Brain Neoplasms (1) · Brain Stem Neoplasms (1) · Cancer Pain (1)
Merck Sharp & Dohme LLC (14) · Chinese University of Hong Kong (2) · Johnson & Johnson Consumer and Personal Products Worldwide (2) · National Institute of Dental and Craniofacial Research (NIDCR) (2) · AstraZeneca (1) · Cancer Research Campaign Clinical Trials Centre (1) · Hospital Universitario Pedro Ernesto (1) · M.D. Anderson Cancer Center (1) · National Cancer Institute, Naples (1) · National Institute on Aging (NIA) (1) · Novartis (1) · Oslo University Hospital (1) · Pfizer (1) · Sheba Medical Center (1) · Tremeau Pharmceuticals, Inc. (1)
United States (5) · China (2) · Italy (2) · Australia (1) · Brazil (1) · Canada (1) · France (1) · Israel (1) · Norway (1) · Poland (1) · Spain (1) · Turkey (Türkiye) (1) · Ukraine (1) · United Kingdom (1)
Enders K.W. Ng, MD (2) · Cesare Gridelli, M.D. (1) · David J. Kerr, MD, FRCP, DSc (1) · Edwin Kuffner, MD (1) · Eric L. Chang, MD (1) · Francesco Perrone, M.D., Ph.D. (1) · Judith Boice, PhD (1) · Leon Thal, MD (1) · Michael J Drescher, MD (1) · Paula Fernstrom (1) · Veronica S Vilela, MD (1)
PMID 12783912, PMID 17513173, PMID 17652651, PMID 18778469, PMID 18922570, PMID 20837956, PMID 25624439, PMID 32797734