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NCT01712360 · ClinicalTrials.gov registry record · Phase 4
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis
A Phase 4 study, sponsored by Merz North America.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT01712360: Completed Phase 4 study, sponsored by Merz North America.
NCT01712360 is a Phase 4 study that has completed, run by Merz North America. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712360, a Phase 4 study, has completed, sponsored by Merz North America.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
Primary Outcome
Variables will be derived from naftifine plasma concentration at day 1. Variables to be analyzed: \- Partial area under the plasma concentration-time curve (0-24 hours postdose) (AUC), as calculated using the linear trapezoid rule. Variables will be derived from naftifine plasma concentration at day 14. Variables to be analyzed: \- Area under the plasma concentration-time curve (AUC) within one dosing interval at steady state (SS). AUCτ,ss= Area under the concentration curve within a dosing i
Interventions
- DRUG NAFT500 (pediatric)
- DRUG NAFT600 (pediatric)
- DRUG NAFT500 (adult)
- DRUG NAFT600 (adult)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT01712360 record still lists
NCT01712360 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 4 interventions - of which NAFT500 (pediatric) is the first listed.
NCT01712360 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01712360 about?
NCT01712360 is a clinical study titled "Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis". This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.
What is the current status of trial NCT01712360?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2012-10. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01712360?
The interventions under investigation include: NAFT500 (pediatric) (DRUG), NAFT600 (pediatric) (DRUG), NAFT500 (adult) (DRUG), NAFT600 (adult) (DRUG).
Who is sponsoring clinical trial NCT01712360?
This trial is sponsored by Merz North America, which has 35 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01712360's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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