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A novel 200 mg itraconazole tablet for the treatment of onychomycosis

A randomized, multicenter, investigator-blinded, parallel-group, placebo-controlled study evaluated the efficacy and safety of itraconazole given as one 200-mg tablet q.d. versus itraconazole given as two 100-mg tablets q.d. for 12 weeks in 1,381 patients with onychomycosis. A 40-week follow-up was included. The superiority of the one itraconazole 200-mg tablet versus placebo was also assessed. The primary endpoint was complete cure of the great toenail at 52 weeks. Complete cure at week 52 was obtained in 22.3, 21.7 and 1% of the itraconazole 200 mg, itraconazole 2 x 100 mg and placebo groups, respectively. Superiority of the itraconazole 200-mg tablet to placebo (P < 0.001) was demonstrated and the itraconazole 200-mg tablet was ...