Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)
Phase 3
Completed
- Conditions
- Knee Osteoarthritis
- Registration Number
- NCT00367315
- Lead Sponsor
- Novartis
- Brief Summary
This study will evaluate the efficacy and safety of using lumiracoxib in the treatment of patients with knee osteoarthritis (OA)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1684
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 peptic 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 on a 0-100 mm Visual Analog Scale (VAS) at 13 weeks. Patient's global assessment of disease activity on a 0-100 mm VAS at 13 weeks. Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score at 13 weeks.
- 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
🇨🇭Basel, Switzerland