Status:
COMPLETED
6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis
Lead Sponsor:
Novartis
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00170872
Start Date
November 1 2004
Last Update
May 21 2012
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