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NCT00001940 · ClinicalTrials.gov registry record · Phase 3
Voriconazole to Treat Fungal Infections
A Phase 3 study of Mycoses, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT00001940: Completed Phase 3 study of Mycoses, sponsored by National Cancer Institute (NCI).
NCT00001940 is a Phase 3 study of Mycoses that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, below the 333-participant average among 7 other Mycoses trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001940, a Phase 3 study of Mycoses, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no approved therapies, and in patients who did not improve with or could not tolerate standard therapy. It will evaluate the drug's safety, effectiveness, and toleration in these patients. Patients previous enrolled in protocol 99-C-0094 who improved with voriconazole treatment are eligible for this study. Before beginning treatment, patients will have a physical examination, including blood and urine tests, and an eye examination. They may also have X-ray or CT imaging. Voriconazole will then be given twice a day either by infusion into a vein or by tablets taken by mouth for up to 12 weeks. Patients will be examined at weeks 4, 8 and 12 of the study and one week after treatment stops. Blood and urine samples will be collected at each visit. An eye examination will be done at the end of the treatment period and at other visits if vision problems develop. Voriconazole is active against fungal infections and may produce fewer side effects than standard therapy.
Conditions Studied
Interventions
- DRUG Voriconazole
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 1999-12 |
| Est. Completion | 2001-07 |
| Phase | Phase 3 |
What the finished NCT00001940 record still lists
NCT00001940 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 333-participant average among 7 other Mycoses trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Mycoses appearing as the primary indexed condition, and to 1 intervention - of which Voriconazole is the first listed.
NCT00001940 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001940 about?
NCT00001940 is a clinical study titled "Voriconazole to Treat Fungal Infections". Voriconazole is a new drug developed to treat fungal infections. As of March 1999, the drug had been studied in more than 1,900 healthy volunteers or patients with fungal infections. This study will test extended use of voriconazole in patients with serious fungal infections for which there are no a...
What is the current status of trial NCT00001940?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 1999-12. Estimated completion is 2001-07.
What conditions does trial NCT00001940 study?
This clinical trial studies the following conditions: Mycoses.
What interventions are being tested in trial NCT00001940?
The interventions under investigation include: Voriconazole (DRUG).
Who is sponsoring clinical trial NCT00001940?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001940 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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