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

NCT00475800

CCOX189A2360E1

Details and patient eligibility

About

This 39-week, open label 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 CCOX189A2360 study.

Enrollment: 833 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have completed the core CCOX189A2360 study
• Males and females over the 18 years old

Exclusion criteria

• Treatment in the extension study is not considered appropriate by the treating physician
• Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)