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NCT00390780 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients
A Phase 3 study, sponsored by Valerio Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 578
- Enrollment target
NCT00390780: Completed Phase 3 study, sponsored by Valerio Therapeutics.
NCT00390780 is a Phase 3 study that has completed, run by Valerio Therapeutics. The registered enrollment target is 578 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00390780, a Phase 3 study, has completed, sponsored by Valerio Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 578 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
Primary Outcome
Murray scoring scale range: extent of oral lesions (signs) 0 (none) to 3 (extensive or confluent), ordinal; symptoms (soreness/burning) 0 (absent) to 3 (severe), ordinal. Clinical cure was defined as a complete resolution of signs and symptoms (extent of oral lesions score = 0, symptoms score = 0). Clinical failure was defined as any patient who failed to be clinically cured by the treatment.
Interventions
- DRUG Clotrimazole
- DRUG miconazole Lauriad
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 578 participants |
| Start Date | 2006-07 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00390780 record still lists
NCT00390780 is an interventional study that assigns participants to a tested intervention. The registered 578 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 2 interventions - of which Clotrimazole is the first listed.
NCT00390780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00390780 about?
NCT00390780 is a clinical study titled "Efficacy and Safety Study of Miconazole Lauriad to Treat Oropharyngeal Candidiasis in HIV Patients". The purpose of this study is to evaluate the clinical cure of miconazole Lauriad 50 mg (1x50mg) Bioadhesive buccal tablets compared with clotrimazole troches (5x10mg) after 14 days of treatment (at the test of cure visit, at Day 17-19).
What is the current status of trial NCT00390780?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 578 participants. The study started on 2006-07. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00390780?
The interventions under investigation include: Clotrimazole (DRUG), miconazole Lauriad (DRUG).
Who is sponsoring clinical trial NCT00390780?
This trial is sponsored by Valerio Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00390780's enrollment target sits among peer trials
578 661st of 2000 higher than 1,340 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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