Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis(OA)
Phase 3
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00475800
- Lead Sponsor
- Novartis
- Brief Summary
This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 833
Inclusion Criteria
- Have completed the core CCOX189A2360 study
- Males and females over the 18 years old
Exclusion Criteria
- Treatment in the extension study is not considered appropriate by the treating physician
- Non-compliance or major protocol violation of the core study
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
- Secondary Outcome Measures
Name Time Method Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit Patient's global assessment of disease activity by visit Physician's global assessment of disease activity by visit.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇨🇦Brampton, Ontario, Canada