Safety and Efficacy of Celecoxib Versus Naproxen in the 6-month Treatment of Knee Osteoarthritis

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the safety and efficacy of celecoxib versus naproxen for the treatment of knee osteoarthritis

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer; Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Treatments: Celecoxib; Naproxen

Criteria

Inclusion Criteria:

• Osteoarthritis of the knee as defined by the American College of Rheumatology criteria in a flare state at baseline visit

• Functional Capacity Classification of I-III

Exclusion Criteria:

• Inflammatory arthritis or gout/pseudo-gout with an acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)

• Received acetaminophen within 24 hours of the baseline visit

• Acute joint trauma at index joint within the past 3 months with active symptoms

• History of gastrointestinal (GI) perforation, obstruction, or bleeding

• Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication

• Received corticosteroids or hyaluronic acid within certain timeframe before study