Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

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

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]).

Inclusion Criteria:

• Diagnosis of primary hip osteoarthritis
• Qualifying pain intensity in the hip joint
• Requiring NSAID therapy

Exclusion Criteria:

• 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)
• Liver disorder
• History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment

Other protocol-defined exclusion criteria may apply.