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

Phase 3CompletedNCT00366938

Novartis1,464 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,464

Conditions

Osteoarthritis, Knee

Interventions

LumiracoxibDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.

Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.

Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.

Secondary Outcomes

Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.

Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Patient's health status using the Short Form-36 (SF-36), at week 13.

Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.

Data from ClinicalTrials.gov

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