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

NCT00491764 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2017-04-07

Study results available
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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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-12-31
Completion
2008-12-31

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00491764 on ClinicalTrials.gov