Clinical evaluation of 'Osmosin' versus piroxicam.

A single-blind, randomized trial was carried out in 30 out-patients with osteoarthritis to compare the efficacy and tolerability of the new osmotic-release formulation, 'Osmosin' (7 mg indomethacin per hour over a period of approximately 10 hours), with that of piroxicam. Patients received a single dose of one 'Osmosin' or 20 mg piroxicam per day for 4 weeks. The results of objective and subjective assessments of disease symptoms showed that both treatments produced statistically significant improvements from baseline and no significant differences between the groups were observed. Three patients in the piroxicam group experienced moderate to severe gastro-intestinal problems and 1 patient dropped out after 2 weeks because of lack of efficacy. No side-effects were reported in the group on 'Osmosin' and all 15 patients completed the study. Data on the incidence of indomethacin-related side-effects from two open multi-centre studies involving large numbers of patients with osteoarthritis are discussed.