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

• Change from baseline in American Pain Society Modified Brief Pain Inventory Short Form pain scores [ Time Frame: Days 1-7 ] [ Designated as safety issue: No ]
• Change from baseline in patient's assessment of arthritis pain according to visual analogue scale [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
• Change from baseline in patient and physician global assessments of arthritis [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
• Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• The Pain Satisfaction Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• The Patient Health Questionnaire (PHQ-9) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• Measurement of upper gastrointestinal tolerability [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
• Adverse events [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
• Laboratory test results [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
• Vital signs [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: Yes ]
• Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]

To compare the efficacy and safety of celecoxib versus ibuprofen in subjects with osteoarthritis (OA) of the knee.

• Drug: Ibuprofen
  800 mg oral tablet 3 times daily with meals for 6 weeks
• Drug: Placebo
  Matched placebo orally for 6 weeks
• Drug: Celecoxib
  200 mg oral capsule once daily with morning meal for 6 weeks

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

Inclusion Criteria:

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:

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