Efficacy and Safety of Celecoxib Versus Ibuprofen in the Treatment of Osteoarthritis of the Knee (United States)

• Drug: Ibuprofen
  
  800 mg oral tablet three time daily with meals for 6 weeks
• Drug: celecoxib
  
  200 mg oral capsule once daily with morning meal for 6 weeks
• Other: placebo
  
  matched placebo orally for 6 weeks

• Experimental: Ibuprofen
  
  Intervention: Drug: Ibuprofen
• Experimental: Celecoxib
  
  Intervention: Drug: celecoxib
• Placebo Comparator: placebo
  
  Intervention: Other: placebo

Inclusion Criteria:

• Aged >= 40 years old
• Diagnosed with OA of the knee according to the American College of Rheumatology and OA in flare state at baseline visit
• Functional capacity class of I-III

Exclusion Criteria:

• Inflammatory arthritis or gout or pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
• Acute joint trauma at index joint within the past 3 months with active symptoms
• Score of >=20 on PHQ-9 or score of >=1 on PHQ-9 item i
• Use of mobility assisting device for <6 weeks or use of walker