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NCT00443898 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 518
- Enrollment target
NCT00443898: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT00443898 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 518 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00443898, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 518 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise
Interventions
- DRUG Placebo
- DRUG terbinafine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 518 participants |
| Start Date | 2006-12 |
| Phase | Phase 3 |
What the finished NCT00443898 record still lists
NCT00443898 is an interventional study that assigns participants to a tested intervention. The registered 518 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00443898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00443898 about?
NCT00443898 is a clinical study titled "Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail". 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 d...
What is the current status of trial NCT00443898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 518 participants. The study started on 2006-12.
What interventions are being tested in trial NCT00443898?
The interventions under investigation include: Placebo (DRUG), terbinafine (DRUG).
Who is sponsoring clinical trial NCT00443898?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00443898's enrollment target sits among peer trials
518 723rd of 2000 higher than 1,277 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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