• Osteoarthr. Cartil. · Apr 2002

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Efficacy and safety of the COX-2 specific inhibitor valdecoxib in the management of osteoarthritis of the hip: a randomized, double-blind, placebo-controlled comparison with naproxen.

    • W Makarowski, William W Zhao, Terry Bevirt, and David P Recker.
    • Rheumatology Associates of NW Pennsylvania, Erie, Pennsylvania, USA.
    • Osteoarthr. Cartil. 2002 Apr 1;10(4):290-6.

    ObjectiveNon-steroidal antiinflammatory agents are commonly used to treat pain and inflammation associated with osteoarthritis (OA), but have poor gastrointestinal (GI) tolerability. This study compared the efficacy of the COX-2 specific inhibitor valdecoxib with naproxen and placebo, in treating symptomatic OA of the hip.DesignThis multicenter, randomized, double-blind 12-week study compared the efficacy and tolerability of single daily doses of valdecoxib 5 mg and 10 mg with placebo or naproxen 500 mg BID. Efficacy was assessed by Patient's and Physician's Global Assessment of Arthritis, and the WOMAC (Western Ontario and McMasters) OA Individual and Composite Indices. The incidence of adverse events was monitored throughout the study.ResultsValdecoxib was clinically and statistically superior to placebo for Patient's and Physician's Global Assessment of Arthritis and for all WOMAC OA Indices over the 12 week study period (PConclusionsSingle daily doses of valdecoxib 5 mg and 10 mg were similar to naproxen and superior to placebo, in treating symptomatic OA of the hip. Both doses of valdecoxib were well tolerated and demonstrated improved GI tolerability compared to naproxen.Copyright 2002 Published by Elsevier Science Ltd on behalf of OsteoArthritis Research Society International.

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