Largest arthritis clinical trial begins

Published: 1-Jul-2002
Regulatory


The world's largest arthritis clinical trial, TARGET (Therapeutic Arthritis Research & Gastrointestinal Event Trial), has been launched to compare Novartis's investigational drug compound Prexige (lumiracoxib/COX189) with the nonsteroidal anti-inflammatory drugs (NSAIDs) ibuprofen and naproxen over 12 months. Prexige is an innovative COX-2 inhibitor currently being studied for the treatment of symptoms of arthritis and pain. In particular, TARGET will examine the treatment's gastrointestinal and cardiovascular safety.

The study will evaluate more than 18,000 patients worldwide. Participants will be men and women of 50 years and older who are symptomatic sufferers of osteoarthritis. TARGET is an international, multicentre, stratified, randomised, double-blind, double-dummy, active-controlled, parallel group trial. The TARGET protocol has been reviewed by the FDA.

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