Efficacy and Safety of Lumiracoxib in Patients With Primary Knee Osteoarthritis (OA)

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

Summary

This 39-week, active controlled, 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 CCOX189A2361 study.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Celecoxib; Diclofenac; Lumiracoxib

Criteria

Inclusion Criteria:

• Any patient who completed the core study 2361 may enter the extension trial upon signing informed consent. A patient is defined as completing if he/she completed the core study 2361 up to and including Visit 6 (week 13) without a major protocol violation.

Exclusion Criteria:

• Those patients for whom continued treatment in the extension study is not considered appropriate by the treating physician

• Those patients who were non-compliant or who demonstrated a major protocol violation in the core study.

Other protocol-defined inclusion/exclusion criteria may apply