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NCT00356915 · ClinicalTrials.gov registry record · Phase 3
Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.
A Phase 3 study, sponsored by Stiefel, a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,381
- Enrollment target
NCT00356915: Completed Phase 3 study, sponsored by Stiefel, a GSK Company.
NCT00356915 is a Phase 3 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 1,381 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00356915, a Phase 3 study, has completed, sponsored by Stiefel, a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,381 participants
- Enrollment target
Study Summary
Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100 mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200 mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.
Primary Outcome
This study was designed to evaluate the superiority of itraconazole tablets to placebo tablets. Clinical Cure was defined as an IGA score of 0 for the target toenail; Mycological Cure was defined as a negative potassium hydroxide (KOH) exam and a negative culture for dermatophytes of the target toenail.
Interventions
- DRUG Placebo tablets
- DRUG Itraconazole 100mg capsules
- DRUG Itraconazole 200mg tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,381 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
What the finished NCT00356915 record still lists
NCT00356915 is an interventional study that assigns participants to a tested intervention. Its 1,381 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo tablets is the first listed.
NCT00356915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00356915 about?
NCT00356915 is a clinical study titled "Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.". Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the t...
What is the current status of trial NCT00356915?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,381 participants. The study started on 2006-07. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00356915?
The interventions under investigation include: Placebo tablets (DRUG), Itraconazole 100mg capsules (DRUG), Itraconazole 200mg tablets (DRUG).
Who is sponsoring clinical trial NCT00356915?
This trial is sponsored by Stiefel, a GSK Company, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00356915's enrollment target sits among peer trials
1,381 176th of 2000 higher than 1,825 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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