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NCT00373685 · ClinicalTrials.gov registry record · Phase 4
GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 8,067
- Enrollment target
NCT00373685: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
NCT00373685 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 8,067 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1457% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00373685, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8,067 participants
- Enrollment target
Study Summary
This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
Primary Outcome
CSULGIE defined as any of the following: gastroduodenal (GD) hemorrhage; gastric outlet obstruction; GD, small or large bowel perforation; small or large bowel hemorrhage; acute gastrointestinal (GI) hemorrhage of unknown origin; small bowel obstruction; clinically significant anemia/blood loss of defined GI origin or presumed occult GI origin.
Interventions
- DRUG Celecoxib
- DRUG Any commercially available NSAID with the indication for osteoarthritis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,067 participants |
| Start Date | 2006-10 |
| Est. Completion | 2010-11 |
| Phase | Phase 4 |
What the finished NCT00373685 record still lists
NCT00373685 is an interventional study that assigns participants to a tested intervention. Its 8,067 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (1457% higher).
The record links to 0 conditions, and to 2 interventions - of which Celecoxib is the first listed.
NCT00373685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00373685 about?
NCT00373685 is a clinical study titled "GI-Reasons- A Trial Of GI Safety Of Celecoxib Compared With Non-Selective Nonsteroidal Antiinflammatory Drugs (NSAIDS)". This study investigates if Celebrex has a lower incident of Gastrointestinal Events than other NSAIDS in subjects with osteoarthritis.
What is the current status of trial NCT00373685?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8,067 participants. The study started on 2006-10. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00373685?
The interventions under investigation include: Celecoxib (DRUG), Any commercially available NSAID with the indication for osteoarthritis (DRUG).
Who is sponsoring clinical trial NCT00373685?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00373685's enrollment target sits among peer trials
8,067 10th of 2000 higher than 1,991 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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