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

Osteoarthritis, Knee Clinical Trial

Official title:

A 13-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Trial of 2 Different Dose Regimens of Lumiracoxib (100 mg od and 200 mg od Initial Dose for Two Weeks Followed by 100 mg od) in Patients With Primary Knee Osteoarthritis, Using Celecoxib (200 mg od) as a Comparator

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366938
• Other study ID #: CCOX189A2360
• Status: Completed
• Phase: Phase 3
• First received: August 18, 2006
• Last updated: May 18, 2012
• Start date: September 2003

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Institutional Review Board Services
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1464
• Est. primary completion date: March 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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, Knee

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals Corporation	E. Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall OA pain intensity in the target knee using a 0-100 mm Visual Analogue Scale (VAS), at week 13.
Primary	Patient's global assessment of disease activity using a 0-100 mm VAS, at week 13.
Primary	Patient's functional status using Western Ontario and McMaster Universities Arthritis Index (WOMAC©) total score, at week 13.
Secondary	Overall OA pain intensity in the target knee using 0-100 mm VAS, at weeks 2, 4, 8.
Secondary	Patient's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.
Secondary	Patient's functional status using WOMAC© Likert 3.1 sub-scale scores and total score, at weeks 2, 8, 13.
Secondary	Patient's health status using the Short Form-36 (SF-36), at week 13.
Secondary	Physician's global assessment of disease activity using 0-100 mm VAS, at weeks 2, 4, 8.