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

Novartis

Status and phase

Completed

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: lumiracoxib

Study type

Interventional

Funder types

Industry

Identifiers

NCT00476034

CCOX189A2361E1

Details and patient eligibility

About

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.

Enrollment

1,312 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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