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Generated: December 12, 2018

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CLINICAL TRIALS PROFILE FOR TERBINAFINE HYDROCHLORIDE

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Clinical Trials for Terbinafine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00117754 Terbinafine Compared to Griseofulvin in Children With Tinea Capitis Completed Novartis Phase 3 Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
NCT00117767 Terbinafine Compared to Griseofulvin in Children With Tinea Capitis Completed Novartis Pharmaceuticals Phase 3 Tinea capitis is a dermatophyte infection of the scalp hair follicles, which occurs primarily in children. Hair loss, hair breakage, scaling, plus various degrees of erythema, pustules and pruritus are the primary clinical signs which can be associated with tinea capitis. The infection is caused by a relatively small group of dermatophytes in the genera Trichophyton and Microsporum. Terbinafine hydrochloride is a synthetic allylamine derivative antifungal agent. This study will evaluate the efficacy and safety of terbinafine in children with tinea capitis.
NCT00253305 Topical Gel Anti-Fungal Agent for Tinea Unguium Completed MediQuest Therapeutics Phase 2 The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis). The formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety. Once the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.
NCT00386802 Antifungal Use in Oncohematological Neutropenic Patients Completed PETHEMA Foundation Phase 4 Primary purpose: Frequency of use of broad-spectrum antifungals in the episode of neutropenia. Secondary purposes:To determine the safety and toxicity measure by: 1. Frequency of Invader Fungal Infection. 2. Frequency of global use of broad-spectrum antifungals as amphotericine, itraconazole, voriconazole, caspofungin, terbinafine, during the period of study. 3. Mortality 4. Development of nephrotoxicity 5. Use of galactomannan in this clinical context 6. Time of administration of empirical antifungal therapy of broad-spectrum.
NCT00443820 Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail Completed Novartis Pharmaceuticals Phase 3 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.
NCT00443898 Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail Completed Novartis Pharmaceuticals Phase 3 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.
NCT00459537 Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis Completed Novartis Phase 3 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Terbinafine Hydrochloride

Condition Name

Condition Name for Terbinafine Hydrochloride
Intervention Trials
Onychomycosis 13
Healthy 5
Tinea Pedis 2
Tinea Capitis 2
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Condition MeSH

Condition MeSH for Terbinafine Hydrochloride
Intervention Trials
Onychomycosis 15
Tinea 4
Tinea Pedis 3
Mycoses 3
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Clinical Trial Locations for Terbinafine Hydrochloride

Trials by Country

Trials by Country for Terbinafine Hydrochloride
Location Trials
United States 55
Canada 4
Spain 3
Thailand 2
Germany 2
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Trials by US State

Trials by US State for Terbinafine Hydrochloride
Location Trials
Oregon 4
Missouri 4
Pennsylvania 4
Texas 4
Florida 3
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Clinical Trial Progress for Terbinafine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Terbinafine Hydrochloride
Clinical Trial Phase Trials
Phase 4 5
Phase 3 6
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Terbinafine Hydrochloride
Clinical Trial Phase Trials
Completed 26
Not yet recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Terbinafine Hydrochloride

Sponsor Name

Sponsor Name for Terbinafine Hydrochloride
Sponsor Trials
Novartis Pharmaceuticals 3
Novartis 3
Teva Pharmaceuticals USA 2
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Sponsor Type

Sponsor Type for Terbinafine Hydrochloride
Sponsor Trials
Industry 25
Other 10
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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Merck
Citi
Medtronic
US Army
McKesson
US Department of Justice
AstraZeneca
Julphar

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