At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 8,067 enrolled
Drug / intervention
Celecoxib +1 moredrug
Likely dose
Not stated in 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.
Gastrointestinal (GI) Randomized Event And Safety Open-Label NSAID Study (GI-Reasons): A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS) In Osteoarthritis Patients
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Sep 8, 2006·Updated Mar 3, 2021
In Brief
A Phase 4 clinical trial evaluating Celecoxib and Any commercially available NSAID with the indication for osteoarthritis for Osteoarthritis. Completed, enrolled 8,067 participants across 777 sites in 2 countries.
Detailed Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 2006
Enrollment StartOct 2006
Primary CompletionNov 2010
TodayJul 2026
First PostedSep 8, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 19.8 years ago
Interventions
Celecoxibdrug
open-label
Any commercially available NSAID with the indication for osteoarthritisdrug
dosing as per USPI label related to the chosen commercially marketed NSAID