Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis
Phase 3
Completed
- Conditions
- Osteoarthritis, Hip
- Registration Number
- NCT00154219
- Lead Sponsor
- Novartis
- Brief Summary
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 \[NSAIDs\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Patient's global assessment of disease activity (VAS) after 13 weeks of treatment WOMAC 3.1 LK questionnaire after 13 weeks of treatment
- Secondary Outcome Measures
Name Time Method Actual OA pain intensity at 12 hours post-dose by visit Overall OA pain intensity (VAS)by visit Physician's global assessment of disease activity (VAS) by visit Number of rescue tablets taken during the study Response to treatment according to OARSI criteria by visit
Trial Locations
- Locations (2)
Various Sites
π¬π§Multiple Cities, United Kingdom
For US Site Information, contact Novartis Pharmaceuticals
πΊπΈEast Hanover, New Jersey, United States