Clinical trial
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride…
NCT00459537 · Novartis, Industry · Completed
Key facts
| NCT number | NCT00459537 |
|---|---|
| Title | Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis |
| 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… |
| Lead sponsor | Novartis, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Onychomycosis |
| Intervention type | Drug |
| Interventions | terbinafine hydrogen chloride, amorolfine nail lacquer |
| Enrollment | 1,029 |
| Start date | Mar 1, 2007 |
| Primary completion | Jan 1, 2009 |
| Completion | Jan 1, 2009 |
| First posted | Apr 12, 2007 |
| Last update posted | May 6, 2011 |
| Countries | Finland, France, Germany, Hungary, Iceland, Norway, Poland, Russia, Spain, Turkey (Türkiye) |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: