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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00491764 |
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.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: SCH 56592 Drug: Terbinafine Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 180 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Posaconazole 1: Experimental
Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
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Drug: SCH 56592
Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks.
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Posaconazole 2: Experimental
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
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Drug: SCH 56592
Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
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Posaconazole 3: Experimental
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
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Drug: SCH 56592
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
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Posaconazole 4: Experimental
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
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Drug: SCH 56592
Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
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Terbinafine: Active Comparator
Terbinafine 250 mg QD for 12 weeks.
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Drug: Terbinafine
Terbinafine 250 mg QD for 12 weeks.
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Placebo: Placebo Comparator
Placebo for 24 weeks.
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Drug: Placebo
Placebo for 24 weeks.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The subject must meet ALL the criteria listed below for entry:
Woman of child-bearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the study.
Exclusion Criteria:
The subject will be excluded from entry if ANY of the criteria listed below are met:
Subject with one or more of the following conditions on the target toenail:
Responsible Party: | Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group ) |
Study ID Numbers: | P05082 |
Study First Received: | June 25, 2007 |
Last Updated: | December 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00491764 |
Health Authority: | United States: Food and Drug Administration |
Mycoses Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole Miconazole |
Tioconazole Posaconazole Tinea Terbinafine Dermatomycoses |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents Nail Diseases Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Antifungal Agents Antibiotics, Antifungal Enzyme Inhibitors Infection Pharmacologic Actions |