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Sponsored by: |
Novartis Pharmaceuticals |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00443820 |
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
Condition | Intervention | Phase |
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Onychomycosis |
Drug: terbinafine Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Vehicle-Controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis |
Enrollment: | 526 |
Study Start Date: | December 2006 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
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Drug: terbinafine
Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
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2: Placebo Comparator
Vehicle (placebo) for 48 weeks
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Drug: Placebo
Vehicle (placebo) once daily for 48 weeks
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3: Experimental
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
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Drug: terbinafine
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
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4: Placebo Comparator
Vehicle (placebo) for 24 weeks
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Drug: Placebo
Vehicle (placebo) once daily for 24 weeks
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Ages Eligible for Study: | 12 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CSFO327N2302 |
Study First Received: | March 2, 2007 |
Last Updated: | March 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00443820 History of Changes |
Health Authority: | United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices |
Toenail fungus Onychomycosis Nail fungus Toenail fungal infection |
Tinea unguium Dermatophytes Foot dermatoses |
Mycoses Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole Miconazole |
Antifungal Agents Tioconazole Tinea Terbinafine Dermatomycoses |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Enzyme Inhibitors Infection Pharmacologic Actions Mycoses Skin Diseases, Infectious |
Onychomycosis Nail Diseases Antifungal Agents Therapeutic Uses Tinea Dermatomycoses Terbinafine |