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NCT00702507 · ClinicalTrials.gov registry record · Phase 4

Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants

A Phase 4 study, sponsored by Stiefel, a GSK Company.

Completed
Registry status
Phase 4
Development phase
200
Enrollment target

NCT00702507: Completed Phase 4 study, sponsored by Stiefel, a GSK Company.

NCT00702507 is a Phase 4 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00702507, a Phase 4 study, has completed, sponsored by Stiefel, a GSK Company.

COMPLETED
Registry status
Phase 4
Development phase
200 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

Primary Outcome

OC was defined as both clinical (therapeutic) cure with total resolution of signs/symptoms (no clinical signs of infection) and microbiological cure with mycological eradication (both negative potassium hydroxide \[KOH\] and culture results). Participants who had OC were categorized as "Successes"; those without OC were categorized as "Failures." Any discontinued or lost to follow-up participant was also considered a failure.

Interventions

  • DRUG 0.25 % Miconazole Nitrate Ointment

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2007-05
Est. Completion 2010-12
Phase Phase 4
Stiefel, a GSK Company

37 total trials

What the finished NCT00702507 record still lists

NCT00702507 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).

The record links to 0 conditions, and to 1 intervention - of which 0.25 % Miconazole Nitrate Ointment is the first listed.

NCT00702507 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00702507 about?

NCT00702507 is a clinical study titled "Prospective Two-Year Study to Assess Miconazole Nitrate Resistance in Neonates and Infants". The purpose of this study is to determine whether repeated use of 0.25% miconazole nitrate ointment in newborns and infants with a yeast infection in the diaper area causes the yeast to become resistant to the drug.

What is the current status of trial NCT00702507?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2007-05. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00702507?

The interventions under investigation include: 0.25 % Miconazole Nitrate Ointment (DRUG).

Who is sponsoring clinical trial NCT00702507?

This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00702507's enrollment target sits among peer trials

200 407th of 2000 higher than 1,556 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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Source: ClinicalTrials.gov NCT00702507, the US trial registry maintained by the National Library of Medicine. NCT00702507 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.