Efficacy and Safety Study of Lumiracoxib in Patients With Primary Hip Osteoarthritis

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154219
• Other study ID #: CCOX189A2367
• Status: Completed
• Phase: Phase 3
• First received: September 7, 2005
• Last updated: May 18, 2012
• Start date: November 2004

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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]).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Lumiracoxib (drug)

Locations

Country	Name	City	State
Canada	Various Sites	Multiple Cities
Germany	Various Sites	Multiple Cities
Italy	Various Sites	Multiple Cities
United Kingdom	Various Sites	Multiple Cities
United States	For US Site Information, contact Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	WOMAC 3.1 LK questionnaire after 13 weeks of treatment
Primary	Patient's global assessment of disease activity (VAS) after 13 weeks of treatment
Secondary	Overall OA pain intensity (VAS)by visit
Secondary	Physician's global assessment of disease activity (VAS) by visit
Secondary	Response to treatment according to OARSI criteria by visit
Secondary	Actual OA pain intensity at 12 hours post-dose by visit
Secondary	Number of rescue tablets taken during the study