6 Week Open-label Trial With Lumiracoxib 200mg o.d. in Primary Knee Osteoarthritis or Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study tested the safety, tolerability and efficacy of lumiracoxib - a COX-2 inhibitor- in patients with primary knee osteoarthritis or rheumatoid arthritis.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Diclofenac; Lumiracoxib

Criteria

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