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Sponsored by: |
Novartis |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00443898 |
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 |
---|---|---|
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 |
Estimated Enrollment: | 500 |
Study Start Date: | December 2006 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) for 48 weeks
|
Drug: terbinafine
Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
|
2: Placebo Comparator
vehicle (placebo) for 48 weeks
|
Drug: Placebo
vehicle (placebo) once daily for 48 weeks
|
3: Experimental
Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) for 24 weeks
|
Drug: terbinafine
Active terbinafine hydrochloride (HCl) Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
|
4: Placebo Comparator
vehicle (placebo) for 24 weeks
|
Drug: Placebo
vehicle (placebo) once daily for 24 weeks
|
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 | Novartis Pharmaceuticals, One Health Plaza, East Hanover, NJ 07936-1080, Tel.: 862-778-8300 |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSFO327N2301 |
Study First Received: | March 5, 2007 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00443898 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Iceland: Ministry of Health and Social Security |
Toenail fungus Onychomycosis Nail fungus Toenail fungal infection |
Tinea unguium Dermatophytes Foot dermatoses |
Mycoses Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole |
Miconazole Tioconazole Tinea Terbinafine Dermatomycoses |
Anti-Infective Agents Nail Diseases Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Antifungal Agents Enzyme Inhibitors Infection Pharmacologic Actions |