Reports on clinical efficacy and safety of generic medicines are scarce in Japan. This multi-center open-labeled collaborative study was conducted to investigate the therapeutic effect, safety and usefulness of Nedoril
® 125 mg Tablets, one of the generic medicines, for toenail onychomycosis. In 98 patients suffering from onychomycosis in the big toe with opacity ratio greater or equal to 5, the medicine was orally administered once a day for 24 weeks, and clinical findings (opacity ratio, thickening), mycological factor, compliance, adverse events and laboratory test values were recorded before and 4, 8, 12, 16 and 24 weeks after the administration. Of a total of 98 patients, 87, after exclusion of 11 who did not go to the clinic for personal reasons, were included in the safety analysis, and 79, after exclusion of 8 who stopped the study within 12 weeks for adverse events, were included in the therapeutic effect and usefulness analysis. The clinical improvement rate of the affected nail area was 84.8%, the total effect determined by the clinical improvement rate and the mycological effect was 74.4%, safety determined by the incidence of adverse events and abnormal laboratory test values was 88.5%, and usefulness determined by total effect and safety was 72.1%. These results suggest that Nedoril
® 125 mg Tablets is a highly useful therapeutic generic medicine for patients with toenail onychomycosis.
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