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SYNOPSIS

In a double-blind parallel study zomepirac sodium was compared with placebo in the treatment of muscle-contraction headache. Eighty patients with histories of recurrent muscle-contraction headaches were given either zomepirac 100 mg, zomepirac 50 mg, or placebo. Patients submitted evaluations for pain relief and analgesic acceptability over a range of four headache episodes. In addition, global evaluations were made by the patients and by the investigator.

In the first headache episode zomepirac sodium 100 mg was significantly superior to placebo in pain relief (p = 0.030), and in analgesic acceptability (p = 0.006). Average values across all episodes indicated a significant linear dose response for zomepirac in analgesic acceptability (p<0.05). Global evaluations showed zomepirac sodium 100 mg to be significantly superior to placebo (p<0.05). The incidence of adverse effects did not vary significantly among treatment groups.

Results of the study suggest that zomepirac sodium will be a useful non-narcotic agent in the treatment of recurrent muscle-contraction headaches requiring the use of a prescription analgesic.