A double-blind comparison of 'Osmosin', benoxaprofen and placebo in the treatment of osteoarthritis.
A double-blind crossover trial using the double-dummy technique was carried out in 30 patients with osteoarthritis. The original design was to compare the efficacy and tolerability of 1 'Osmosin', the new osmotic-release formulation delivering 7 mg indomethacin per hour for approximately 10 hours, with that of benoxaprofen (600 mg). Each treatment was to have been given as a single daily dose, at night, for 4 weeks, before crossing over to the alternative medication. Because of the withdrawal of benoxaprofen from the U.K. market just as 14 patients had completed their first treatment period, the study was continued as an 'Osmosin' versus placebo trial after crossover. Comparison of the results of first treatments showed that 'Osmosin' was significantly better than placebo and at least as effective as benoxaprofen in reducing pain scores, particularly day and weight-bearing pain. The crossover data supported these findings. 'Osmosin' proved to be well tolerated, with a side-effect profile similar to that of placebo.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009995:Osmosis; D010003:Osteoarthritis / Q000188:drug therapy*; D011422:Propionates / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D011422:Propionates; C011677:benoxaprofen; D007213:Indomethacin