CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24,081 enrolled
Drug / intervention
celecoxib +2 moredrug
Likely dose
celecoxib 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00346216
NCT00346216Phase 4Completed

A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 29, 2006·Updated Mar 3, 2021

In Brief

A Phase 4 clinical trial evaluating celecoxib, Ibuprofen, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 24,081 participants across 1,066 sites in 13 countries.

Detailed Summary

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Brazil, Canada, Colombia, Costa Rica, Hong Kong, Mexico, Panama, Peru, Philippines, Taiwan, Ukraine, United States

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 29, 2006
Enrollment StartOct 4, 2006
Primary CompletionApr 12, 2016
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.0 years ago

Interventions

celecoxibdrug

100 to 200 mg twice daily, taken by mouth

Ibuprofendrug

ibuprofen 600 mg to 800 mg three times daily, taken by mouth

Naproxendrug

naproxen 375mg to 500 mg twice daily, taken by mouth