A Study to Evaluate Efficacy and Safety of Four Posaconazole Regimens With Placebo and Terbinafine in the Treatment of Toenail Onychomycosis (Study P05082AM2)(COMPLETED)

Phase 2 Completed 218 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of oral administration of four dosing regimens of posaconazole relative to placebo and terbinafine, in the treatment of toenail onychomycosis.

Timeline

Start: 2007-06
Primary completion: 2008-12
Completion: 2008-12

Outcome

Met primary endpoint

paper All posaconazole treatment arms had a significantly (P≤0·012) greater proportion of patients with complete cure at week 48 compared with placebo. PMID 21967490 ↗

Publications

Elewski B, Pollak R, Ashton S, Rich P, Schlessinger J, Tavakkol A. A randomized, placebo- and active-controlled, parallel-group, multicentre, investigator-blinded study of four treatment regimens of posaconazole in adults with toenail onychomycosis. Br J Dermatol. 2012 Feb;166(2):389-98. doi: 10.1111/j.1365-2133.2011.10660.x. Epub 2011 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Posaconazole	Small molecule	100 mg	Oral
Subject	Posaconazole	Small molecule	200 mg	Oral
Subject	Posaconazole	Small molecule	400 mg	Oral
Comparator	Terbinafine	Small molecule	250 mg	Oral