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

Novartis

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Drug: Lumiracoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00366938

CCOX189A2360

Details and patient eligibility

About

This study will investigate the efficacy and safety of lumiracoxib in patients with primary knee osteoarthritis (OA).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary osteoarthritis of knee (confirmed by American College of Rheumatology [ACR] criteria).
• Requirement of regular non-steroidal anti-inflammatory drug (NSAID) therapy.

Exclusion criteria

• Evidence of active gastrointestinal ulceration within 12 months prior to the screening visit or history of active gastrointestinal bleeding within the previous 5 years.
• Known hypersensitivity to analgesics, antipyretics, or NSAIDS (including celecoxib).

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind