Efficacy and Safety of Lumiracoxib in Patients With Knee Osteoarthritis (OA).
Phase 3
Completed
- Conditions
- Osteoarthritis, Knee
- Registration Number
- NCT00366938
- Lead Sponsor
- Novartis
- Brief Summary
This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1464
Inclusion Criteria
- Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
- Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.
Exclusion Criteria
- Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
- Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13. Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13. Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
- Secondary Outcome Measures
Name Time Method Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8. Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8. Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13. Patient's health status using the Short Form-36 (SF-36), at week 13. Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Trial Locations
- Locations (1)
Novartis Pharmaceuticals Corporation
🇺🇸E. Hanover, New Jersey, United States