Conditions: Arthritis, Rheumatoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24081
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: subject receives celecoxib and dummy (placebo) ibuprofen and naproxen arm 2: subject receives ibuprofen and dummy (placebo) celecoxib and naproxen arm 3: subject receives naproxen and dummy (placebo) celecoxib and ibuprofen

Interventions: intervention 1: celecoxib intervention 2: Ibuprofen intervention 3: Naproxen
Intervention descriptions: intervention 1: 100 to 200 mg twice daily, taken by mouth intervention 2: ibuprofen 600 mg to 800 mg three times daily, taken by mouth intervention 3: naproxen 375mg to 500 mg twice daily, taken by mouth

Protocol document: