NCT00491764

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

An Investigator-Blinded Study Evaluating the Efficacy and Safety of Four Posaconazole Treatment Regimens With Placebo and Terbinafine in the Treatment of Onychomycosis of the Toenail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	SCH 56592	Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
DRUG	SCH 56592	Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
DRUG	SCH 56592	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
DRUG	SCH 56592	Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
DRUG	Terbinafine	Terbinafine 250 mg QD for 12 weeks.
DRUG	Placebo	Placebo for 24 weeks.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-06-26
• Last updated: 2017-04-07
• Results posted: 2010-01-28