CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 218 enrolled
Drug / intervention
SCH 56592 +5 moredrug
Likely dose
SCH 56592 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00491764
NCT00491764Phase 2Completed
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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

Merck Sharp & Dohme LLC·interventional·Posted Jun 26, 2007·Updated Apr 7, 2017

In Brief

A Phase 2 clinical trial evaluating SCH 56592, Terbinafine, and 1 other intervention for Onychomycosis. Completed, enrolled 218 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOnychomycosis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 26, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.0 years ago

Interventions

SCH 56592drug

Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.

SCH 56592drug

Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.

SCH 56592drug

Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.

SCH 56592drug

Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.

Terbinafinedrug

Terbinafine 250 mg QD for 12 weeks.

Placebodrug

Placebo for 24 weeks.