Comparison of a slow-release indomethacin tablet and naproxen in osteoarthrosis.
A double-blind, crossover study was performed in 21 out-patients with osteoarthrosis of the hip or knee to compare the efficacy and tolerability of a new slow-release formulation (multiple units dose preparation) of indomethacin (50 mg) with those of naproxen (250 mg). After a wash-out period of 1 week, the patients were randomized to receive 2 tablets daily of one or other preparation for 3 weeks. This was followed by another wash-out period of 1 week, whereafter the patients were crossed over to the alternative drug for another 3 weeks. Subjective assessments of pain and objective assessment of joint mobility and the use of acetylsalicylic acid as rescue analgesic were used to evaluate the efficacy of the treatment. Analysis of results from 19 patients showed that both drugs effectively alleviated pain, and there was no difference between indomethacin and naproxen in this respect. There were 2 withdrawals, 1 on naproxen due to inefficacy and 1 on indomethacin due to gastro-intestinal side-effects. Otherwise, the drugs were well tolerated and side-effects occurred to the same extent on both drugs. This study confirms the good efficacy and tolerability of the new slow-release indomethacin preparation.
D000328:Adult; D000368:Aged; D002493:Central Nervous System Diseases / Q000139:chemically induced; D002986:Clinical Trials as Topic; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006621:Hip Joint / Q000503:physiopathology; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D007719:Knee Joint / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009068:Movement; D009288:Naproxen / Q000627:therapeutic use*; D010003:Osteoarthritis / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D010146:Pain / Q000188:drug therapy; D011897:Random Allocation; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets; D009288:Naproxen; D007213:Indomethacin