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NCT01208168 · ClinicalTrials.gov registry record · Phase 3
Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails
A Phase 3 study, sponsored by Promius Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 468
- Enrollment target
NCT01208168: Clinical Trial Phase 3 study, sponsored by Promius Pharma.
NCT01208168 is a Phase 3 study that was terminated before completion, run by Promius Pharma. The registered enrollment target is 468 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01208168, a Phase 3 study, was terminated before completion, sponsored by Promius Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 468 participants
- Enrollment target
Study Summary
The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
Interventions
- DRUG NAB001
- DRUG Vehicle alone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 468 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-07 |
| Phase | Phase 3 |
Why NCT01208168 stopped before completion
NCT01208168 is an interventional study that assigns participants to a tested intervention. The registered 468 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 (39% lower).
The record links to 0 conditions, and to 2 interventions - of which NAB001 is the first listed.
NCT01208168 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01208168 about?
NCT01208168 is a clinical study titled "Safety & Efficacy of NAB001 in the Treatment of Mild to Moderate Onychomycosis of the Toenails". The objectives of this study are to assess the safety of NAB001 for topical treatment of mild to moderate distal onychomycosis of the toenails over 52 weeks and to compare the efficacy of NAB001 to vehicle alone at the end of the study (Week 56) after treating for 52 weeks.
What is the current status of trial NCT01208168?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 468 participants. The study started on 2010-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01208168?
The interventions under investigation include: NAB001 (DRUG), Vehicle alone (DRUG).
Who is sponsoring clinical trial NCT01208168?
This trial is sponsored by Promius Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01208168's enrollment target sits among peer trials
468 816th of 2000 higher than 1,185 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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