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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00459537 |
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild to moderate toenail onychomycosis, for a total treatment duration of 48 weeks.
Condition | Intervention | Phase |
---|---|---|
Onychomycosis |
Drug: terbinafine hydrogen chloride Drug: amorolfine nail lacquer |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Open-Label, Active-Controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride (HCl) Formulation Versus 5% Amorolfine Nail Lacquer for 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis |
Enrollment: | 1029 |
Study Start Date: | March 2007 |
Study Completion Date: | January 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
terbinafine hydrogen chloride
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Drug: terbinafine hydrogen chloride
10 % terbinafine hydrogen chloride (HCL)
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2: Active Comparator
amorolfine nail lacquer
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Drug: amorolfine nail lacquer
5 % amorolfine nail lacquer
|
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
Finland | |
Novartis Investigative Site | |
Various Cities, Finland | |
France | |
Novartis Investigative Site | |
Various Cities, France | |
Germany | |
Novartis Investigative Site | |
Various Cities, Germany | |
Hungary | |
Novartis Investigative Site | |
Various Cities, Hungary | |
Iceland | |
Novartis Investigative Site | |
Various Cities, Iceland | |
Norway | |
Novartis Investigative Site | |
Various Cities, Norway | |
Poland | |
Novartis Investigative Site | |
Various Cities, Poland | |
Russian Federation | |
Novartis Investigative Site | |
Various Cities, Russian Federation | |
Spain | |
Novartis Investigative Site | |
Various Cities, Spain | |
Turkey | |
Novartis Investigative Site | |
Various Cities, Turkey |
Study Director: | Novartis | Novartis |
Responsible Party: | Novartis ( External Affairs ) |
Study ID Numbers: | CSFO327N2303 |
Study First Received: | April 10, 2007 |
Last Updated: | February 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00459537 History of Changes |
Health Authority: | Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: Országos Gyógyszerészeti Intézet; Iceland: Icelandic Medicines Control Agency; Norway: Norwegian Medicines Agency; Poland: Central Register of Clinical Trials; Russia: Ministry of Health and Social Development of the Russian Federation; Spain: Ministry of Health; Turkey: T.C. Sağlık Bakanlığı |
Toenail fungus Onychomycosis Nail fungus Toenail fungal infection |
Tinea unguium Dermatophytes Foot dermatoses |
Mycoses Skin Diseases, Infectious Onychomycosis Skin Diseases Clotrimazole Amorolfin |
Miconazole Antifungal Agents Tioconazole Tinea Terbinafine Dermatomycoses |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Amorolfin Enzyme Inhibitors Infection Pharmacologic Actions Mycoses |
Skin Diseases, Infectious Onychomycosis Nail Diseases Antifungal Agents Therapeutic Uses Tinea Dermatomycoses Terbinafine |