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

• Drug: Celecoxib
  
  200 mg oral capsule once daily for 6 months
• Drug: Naproxen
  
  500 mg oral capsule twice daily for 6 months
• Drug: Placebo
  
  Matched oral placebo for 6 months

• Experimental: A
  
  Intervention: Drug: Celecoxib
• Active Comparator: B
  
  Intervention: Drug: Naproxen
• Placebo Comparator: C
  
  Intervention: Drug: Placebo

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