Completed
PHASE4
INTERVENTIONAL
NCT00346216
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
celecoxib
Type:
DRUG
Description:
100 to 200 mg twice daily, taken by mouth
Name:
Ibuprofen
Type:
DRUG
Description:
ibuprofen 600 mg to 800 mg three times daily, taken by mouth
Name:
Naproxen
Type:
DRUG
Description:
naproxen 375mg to 500 mg twice daily, taken by mouth
Primary Outcomes
Measure:
The First Occurrence of Antiplatelet Trialists Collaboration (APTC) Composite Endpoint, Confirmed by the Clinical Events Committee (CEC).
TimeFrame:
Intent to Treat (ITT) Population - 30 months; Modified ITT (MITT) Population - 42 months
Description:
APTC events are defined as a composite of any of the following events: Death due to CV causes (including cardiac, cerebrovascular, venous thromboembolic, haemorrhagic, other vascular, or unknown cause); Non-fatal MI; Non-fatal stroke (including intracranial hemorrhages, stroke of ischemic or unknown etiology).
Trial Information
NCT ID
NCT00346216
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last Updated
December 15, 2025