NCT00346216

Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

A Randomized, Double Blind, Parallel-group Study Of Cardiovascular Safety In Osteoarthritis Or Rheumatoid Arthritis Patients With Or At High Risk For Cardiovascular Disease Comparing Celecoxib With Naproxen And Ibuprofen

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24,081 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	celecoxib	100 to 200 mg twice daily, taken by mouth
DRUG	Ibuprofen	ibuprofen 600 mg to 800 mg three times daily, taken by mouth
DRUG	Naproxen	naproxen 375mg to 500 mg twice daily, taken by mouth

Timeline

• Start date: 2006-10-04
• Primary completion: 2016-04-12
• Completion: 2016-04-12
• First posted: 2006-06-29
• Last updated: 2021-03-03
• Results posted: 2017-05-01

Locations

1,066 sites across 13 countries: United States, Australia, Brazil, Canada, Colombia, Costa Rica, Hong Kong, Mexico, Panama, Peru, Philippines, Taiwan, Ukraine