{"id":"vioxx","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT00092365","NCT00092339","NCT00140894","NCT00140933","NCT00282386","NCT00165048","NCT00157872","NCT00637949","NCT00092378","NCT00140920","NCT00092352","NCT00038389","NCT00060476","NCT01762891","NCT00092326","NCT00390260","NCT00164892","NCT00092300","NCT00568295","NCT00092313"],"aliases":["Rofecoxib"],"patents":[],"pricing":[],"offLabel":[],"timeline":[],"brandName":"Vioxx","companyId":"m-d-anderson-cancer-center","ecosystem":[],"mechanism":{"target":"Cytochrome c oxidase subunit 2, Prostaglandin E2 receptor EP2 subtype, Prostaglandin G/H synthase 1","novelty":"","modality":"Small molecule","drugClass":"","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"M.D. Anderson Cancer Center","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"Vioxx","indications":{"approved":[{"name":"Dysmenorrhea","diseaseId":"dysmenorrhea","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Juvenile rheumatoid arthritis","diseaseId":"juvenile-rheumatoid-arthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Migraine","diseaseId":"migraine","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Osteoarthritis","diseaseId":"osteoarthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Pain","diseaseId":"pain","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Rheumatoid arthritis","diseaseId":"rheumatoid-arthritis","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00092365","phase":"Phase 3","title":"A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":413,"indication":"Osteoarthritis","completionDate":"2003-11-01"},{"nctId":"NCT00092339","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Effects of Rofecoxib 50 mg and Valdecoxib 40 mg in Patients With Postoperative Dental Pain","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":125,"indication":"Postoperative Pain","completionDate":"2002-09-15"},{"nctId":"NCT00140894","phase":"Phase 4","title":"A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Rofecoxib in Familial Adenomatous Polyposis (FAP)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":62,"indication":"Adenomatous Polyposis Coli","completionDate":"2004-10-11"},{"nctId":"NCT00140933","phase":"Phase 3","title":"A Randomized, Double-Blind, 7-Day Study of the Efficacy and Safety of Rofecoxib Versus Placebo and Diclofenac in Patients With Acute Painful Rotator Cuff Syndrome","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":274,"indication":"Pain","completionDate":""},{"nctId":"NCT00282386","phase":"Phase 3","title":"A Multicenter, Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Study With In-House Blinding to Determine the Effect of 156 Weeks of Treatment With MK0966 on the Recurrence of Neoplastic P","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":2586,"indication":"Colorectal Adenoma","completionDate":"2004-09-01"},{"nctId":"NCT00165048","phase":"Phase 3","title":"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","status":"UNKNOWN","sponsor":"Chinese University of Hong Kong","isPivotal":true,"enrollment":206,"indication":"Cancer of Stomach","completionDate":""},{"nctId":"NCT00157872","phase":"Phase 4","title":"A Multicenter, Randomized, Parallel-Group, 8-Week, Double-Blind, and Active Comparator-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Rofecoxib Tablet 25 mg Once Daily Versus Nap","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":150,"indication":"Rheumatoid Arthritis","completionDate":"2004-09-19"},{"nctId":"NCT00637949","phase":"Phase 3","title":"A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral ","status":"COMPLETED","sponsor":"Novartis","isPivotal":true,"enrollment":309,"indication":"Osteoarthritis","completionDate":"2001-03"},{"nctId":"NCT00092378","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":251,"indication":"Postoperative Pain","completionDate":"2003-12-01"},{"nctId":"NCT00140920","phase":"Phase 4","title":"A Study to Compare Pre-Operative Administration of Rofecoxib Vs Post-Operative Administration of Diclofenac or Rofecoxib in the Treatment of Post-Operative Pain After Total Knee Joint Replacement in P","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"enrollment":11,"indication":"Pain","completionDate":"2004-09-27"},{"nctId":"NCT00092352","phase":"Phase 3","title":"A Randomized, Placebo-Controlled, Parallel-Group, Double -Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients With Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":395,"indication":"Osteoarthritis","completionDate":"2003-12-01"},{"nctId":"NCT00038389","phase":"Phase 1","title":"Phase I Study of Vioxx and Radiation Therapy for Brainstem Glioma","status":"TERMINATED","sponsor":"M.D. Anderson Cancer Center","isPivotal":false,"enrollment":8,"indication":"Glioma, Brain Neoplasms","completionDate":"2005-01"},{"nctId":"NCT00060476","phase":"Phase 3","title":"A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects of Rofecoxib in Decreasing the Risk of Prostate Cancer (ViP Study)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":15000,"indication":"Prostate Cancer","completionDate":"2004-12-08"},{"nctId":"NCT01762891","phase":"NA","title":"CI(R)CA : Coumadin Interaction With Rofecoxib, Celecoxib and Acetaminophen. A Prospective Double-blind, Placebo Controlled Study.","status":"COMPLETED","sponsor":"Hospital Universitario Pedro Ernesto","isPivotal":false,"enrollment":22,"indication":"Antiphospholipid Antibody Syndrome","completionDate":"2009-09"},{"nctId":"NCT00092326","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Po","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":269,"indication":"Postoperative Pain","completionDate":"2002-09"},{"nctId":"NCT00390260","phase":"Phase 3","title":"Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Rofecoxib 50 mg and Hydrocodone 7.5 mg With Acetaminophen 750 mg in Patients With Postoperative Arthroscopic Pain","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":420,"indication":"Pain, Postoperative Arthroscopy","completionDate":"2003-02"},{"nctId":"NCT00164892","phase":"Phase 3","title":"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","status":"UNKNOWN","sponsor":"Chinese University of Hong Kong","isPivotal":true,"enrollment":214,"indication":"Cancer of Stomach","completionDate":""},{"nctId":"NCT00092300","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Single Dose Study of the Effect of Rofecoxib 50 mg and Valdecoxib 20 mg in Patients With Postoperative Dental Pain","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":450,"indication":"Postoperative Pain","completionDate":""},{"nctId":"NCT00568295","phase":"Phase 3","title":"A Four-Week Comparative Study Evaluating Acetaminophen Extended Release (3900 mg/Day) and Rofecoxib (12.5 mg/Day and 25 mg/Day)in the Treatment of Osteoarthritis of the Knee","status":"COMPLETED","sponsor":"Johnson & Johnson Consumer and Personal Products Worldwide","isPivotal":true,"enrollment":403,"indication":"Osteoarthritis of the Knee","completionDate":"2000-10"},{"nctId":"NCT00092313","phase":"Phase 3","title":"A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Study to Evaluate the Efficacy of Rofecoxib and a Dosing Regimen of Oxycodone With Acetaminophen Over 24 Hours in Patients With Po","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","isPivotal":true,"enrollment":271,"indication":"Postoperative Pain","completionDate":"2002-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Small molecule","aiSummary":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}