Naproxen: A novel approach to dose‐flnding efficacy trials in rheumatoid arthritis

Abstract

Because of the unpredictable course of rheumatoid arthritis, a special protocol was devised for a clinical trial of naproxen, a new, nonsteroidal, anti‐inflammatory agent, in 117 patients. Trial design included an open titration phase, permitting individualization of dose and minimizing positive placebo reactions, and a subsequent double‐blind phase during which patients took either naproxen, in the previously established dose, or placebo. Naproxen proved effective in the symptomatic treatment of rheumatoid arthritis at a dose range of 400 to 500 mg a day. At these doses, naproxen was well tolerated and produced no significant gastrointestinal irritation. Extensive laboratory evaluation uncovered no changes suggestive of drug toxicity. Our findings confirm that this is a powerful and efficient trial design that should be considered in the early evaluation of new drugs for the treatment of rheumatoid arthritis.