A double-blind trial comparing indomethacin sustained release capsules (Indocid-R) with indomethacin capsules in patients with rheumatoid arthritis.

A double-blind, controlled and completely randomized trial was conducted in four European rheumatology clinics. Eighty-six patients with a diagnosis of rheumatoid arthritis and prior treatment of at least six months' duration with indomethacin 150 mg/day were studied. Comparisons of the clinical efficacy, tolerability and safety of a new, oral sustained-release formulation of indomethacin were made with a conventional formulation of indomethacin. In all clinical indices of response, the indomethacin sustained-release 75 mg capsule b.i.d. was found to provide relief of symptoms similar to the conventional 50 mg capsule t.i.d. The incidence of overall adverse clinical and laboratory effects was comparable for the two treatments.