NCT00475800

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

Completed Phase 3 Last updated 18 May 2012

What this trial tests

Phase 3 trial testing Lumiracoxib in Osteoarthritis in 833 participants. Completed.

Timeline

1 January 2004

Primary endpoint
1 December 2004

Quick facts

Lead sponsor	Novartis
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	833
Start date	1 January 2004
Primary completion	1 December 2004
Sites	6 locations across United States, Canada

Drugs / interventions tested

• Lumiracoxib (LUMIRACOXIB) — full drug profile →

Conditions studied

• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Novartis — full company profile →

Who can join

18 and older, any sex, with Osteoarthritis.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.