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

Osteoarthritis Clinical Trial

Official title:

A 39-week, Open-label Extension to CCOX189A2360, 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: NCT00475800
• Other study ID #: CCOX189A2360E1
• Status: Completed
• Phase: Phase 3
• First received: May 18, 2007
• Last updated: May 18, 2012
• Start date: January 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 Canada
• Study type: Interventional

Clinical Trial Summary

This 39-week, open label study is designed to assess long-term efficacy, safety and tolerability of lumiracoxib 100mg od in patients with osteoarthritis (OA) of the knee who participated in the 13-week core CCOX189A2360 study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 833
• Est. primary completion date: December 2004
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have completed the core CCOX189A2360 study

• Males and females over the 18 years old

Exclusion Criteria:

• Treatment in the extension study is not considered appropriate by the treating physician

• Non-compliance or major protocol violation of the core study

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Lumiracoxib

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Brampton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess long-term safety and tolerability in patients who were exposed in the core study for 13 weeks to either lumiracoxib, celecoxib or placebo and who will be exposed to lumiracoxib 100 mg od for an additional 39 weeks.
Secondary	Overall OA pain intensity (Target knee) on a 0-100 mm VAS by visit
Secondary	Patient's global assessment of disease activity by visit
Secondary	Physician's global assessment of disease activity by visit.