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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 is a Phase 3 study that has completed, run by Stiefel, a GSK Company. The registered enrollment target is 1,381 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00356915
The ClinicalTrials.gov registry entry for NCT00356915 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,381 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stiefel, a GSK Company, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo tablets is the first listed.
NCT00356915 reports 0 study locations.
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.
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