6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis
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Assess safety and tolerability profile of lumiracoxib in comparison to baseline
Secondary Outcome Measures
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
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
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)
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