Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
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The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).
A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control
Study Start Date :
Actual Primary Completion Date :
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Ages Eligible for Study:
40 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of primary hip osteoarthritis
Qualifying pain intensity in the hip joint
Requiring NSAID therapy
Rheumatoid arthritis or other inflammatory joint disease
Disease or disorder that may interfere with pain assessment of the hip
Open knee/hip surgery within the last year
Past history of heart attack, stroke or angina (chest pain)
History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment
Other protocol-defined exclusion criteria may apply.