Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

• Patient's Assessment of Arthritis Pain, according to VAS [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
• The Western Ontario and McMaster Universities Osteoarthritis Index [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• Patient's and Physician's Global Assessment of Arthritis [ Time Frame: Weeks 2 and 6 ] [ Designated as safety issue: No ]
• The Medical Outcomes Study Sleep Scale [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• Adverse events [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]
• Laboratory tests [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
• Vital signs [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
• Physical examination [ Time Frame: Week 6 ] [ Designated as safety issue: Yes ]
• Serious adverse events [ Time Frame: Up to 30 days after last dose ] [ Designated as safety issue: Yes ]

To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen

• Drug: Celecoxib
  200 mg oral capsule once daily with morning meal for 6 weeks
• Other: Placebo
  Matched oral placebo for 6 weeks

• Experimental: A
  Intervention: Drug: Celecoxib
• Placebo Comparator: B
  Intervention: Other: Placebo

Inclusion Criteria:

Inclusion criteria:

• Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
• Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion Criteria:

Exclusion criteria:

• Inflammatory arthritis or gout/pseudo-gout with 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
• Use of a mobility assisting device for less than six weeks prior to study screening or use of a walker
• 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