6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- OsteoarthritisRheumatoid Arthritis
- Registration Number
- NCT00170872
- Lead Sponsor
- Novartis
- Brief Summary
This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
- Requirement of regular NSAID therapy
- With primary osteoarthritis of the target knee (by ACR Criteria) or with a diagnosis of rheumatoid arthritis (by ACR Criteria)
Exclusion Criteria
- Evidence of active ulceration of the UGI tract within 6 months prior to the screening visit or history of active bleeding of the UGI tract within the previous 5 years. As well as with pyloric or duodenal obstruction or with history of gastrointestinal parasites.
- History of cardiac and cerebral thrombotic/ischemic diseases and/or events
- Patients taking additional NSAIDs (including COX-2 inhibitors) during the course of the study.
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Assess safety and tolerability profile of lumiracoxib in comparison to baseline
- Secondary Outcome Measures
Name Time Method Demonstrate that lumiracoxib 200mg o.d. is effective in treating OA and pain due to RA with respect to overall OA/ RA pain intensity on a 0-100 mm Visual Analog Scale (VAS) after 6 weeks of treatment in comparison to baseline Assess efficacy of lumiracoxib compared to baseline with respect to a) overall OA/ RA pain intensity b) patient's and physician's global assessment of disease activity c) patient functional status Use of rescue medication