Multicenter studies in the United States and Canada of meclofenamate sodium in osteoarthritis of the hip and knee. Double-blind comparison with placebo and long-term experience.
N-(2,6-Dichloro-m-tolyl) anthranilic acid, sodium salt (meclofenamate sodium, Meclomen) was compared to placebo in two controlled multicenter trials of similar design, one in 180 patients with osteoarthritis of the hip and the other in 237 patients with osteoarthritis of the knee. Following one week on placebo to establish a baseline, patients were given meclofenamate sodium (300 mg/day) or placebo for a four-week double-blind controlled period of treatment. Improvement with meclofenamate sodium consistently exceeded that with placebo. In the hip and knee trials, the differences were statistically significant for at least three of the four weekly visits in reduction of pain on walking, pain on starting motion, pain on passive motion, night pain (knee only), and tenderness. Early in the study, statistically significant improvement was also observed in tenderness measures of the knee and fabere measures of hip function. At each weekly observation, significantly better global assessment scores of patient condition were reported by the patients (p less than 0.005) and their physicians (p less than 0.01) in the group receiving meclofenamate sodium in both the hip and knee trials. Overall global improvement was reported in 76% of the patients on drug and 42% of those on placebo. 31% of the patients receiving meclofenamate sodium and 23% receiving placebo reported adverse reactions. Gastrointestinal reactions were more frequent among the patients receiving the drug. The improvement achieved during the double-blind phase was maintained or increased in 359 patients who continued into long-term therapy with meclofenamate sodium. Meclofenamate sodium was judged effective and safe in the treatment of osteoarthritis of the hip and knee.
D000328:Adult; D000368:Aged; D002170:Canada; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006621:Hip Joint; D006801:Humans; D007719:Knee Joint; D008297:Male; D008469:Meclofenamic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D010919:Placebos; D013997:Time Factors; D014481:United States; D062367:ortho-Aminobenzoates / Q000627:therapeutic use*
D010919:Placebos; D062367:ortho-Aminobenzoates; D008469:Meclofenamic Acid