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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 is a Phase 3 study that was terminated before completion, run by Promius Pharma. The registered enrollment target is 468 participants.

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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

FieldValue
Enrollment Target 468 participants
Start Date 2010-09
Est. Completion 2012-07
Phase Phase 3

Sponsor

Promius Pharma

9 total trials

What the Registry Record Tells You About NCT01208168

The ClinicalTrials.gov registry entry for NCT01208168 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 468 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Promius Pharma, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which NAB001 is the first listed.

NCT01208168 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.