A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial of Lumiracoxib (COX189) 100 mg o.d. in Patients With Primary Hip Osteoarthritis Using Celecoxib (200 mg o.d.) as a Positive Control

Novartis2 sites in 2 countries1,200 target enrollmentNovember 2004

ConditionsOsteoarthritis, Hip

DrugsLumiracoxib (drug)

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Osteoarthritis, Hip
Sponsor: Novartis
Enrollment: 1200
Locations: 2
Primary Endpoint: Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy, tolerability, and safety of the investigational drug, lumiracoxib as compared to celecoxib and placebo in subjects with hip osteoarthritis. Both lumiracoxib and celecoxib belong to the same class of drug (COX-2 selective nonsteroidal anti-inflammatory drugs [NSAIDs]).

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

October 2006

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of primary hip osteoarthritis
•Qualifying pain intensity in the hip joint
•Requiring NSAID therapy

Exclusion Criteria

•Rheumatoid arthritis or other inflammatory joint disease
•Disease or disorder that may interfere with pain assessment of the hip
•Open knee/hip surgery within the last year
•Past history of heart attack, stroke or angina (chest pain)
•Liver disorder
•History of severe adverse reactions of any kind under lumiracoxib or celecoxib treatment
•Other protocol-defined exclusion criteria may apply.