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Summary
A double-blind, crossover study was undertaken to compare the efficacy and tolerability of a novel enteric coated 500 mg naproxen tablet with normal release 500 mg naproxen in patients with osteoarthritis. Eighty-eight patients were randomly allocated to receive enteric coated naproxen as a single daily dose of 2 tablets at night or I normal release naproxen tablet twice daily for a period of 3 weeks, followed by the alternative treatment for a further period of 3 weeks. The results of patient and doctor assessments showed that both treatments were increasingly efficacious, with a significant period effect found in the measures for pain on passive movement and duration of morning stiffness. No significant treatment differences were seen in any of the measures of efficacy and tolerability, although there were more withdrawals on normal release than on enteric coated naproxen (p = 0.07). It was concluded that enteric coated naproxen given as a single 1 g dose at night and normal release 500 mg naproxen given twice daily are equally efficacious and well tolerated.