Trials / Completed
CompletedNCT00373685
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 8,067 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 55 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Celecoxib | open-label |
| DRUG | Any commercially available NSAID with the indication for osteoarthritis | dosing as per USPI label related to the chosen commercially marketed NSAID |
Timeline
- Start date
- 2006-10-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2006-09-08
- Last updated
- 2021-03-03
- Results posted
- 2011-11-30
Locations
777 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00373685. Inclusion in this directory is not an endorsement.