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NCT00384527 · ClinicalTrials.gov registry record · Phase 3
Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease
A Phase 3 study, sponsored by Romark Laboratories L.C..
- Terminated
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT00384527: Clinical Trial Phase 3 study, sponsored by Romark Laboratories L.C..
NCT00384527 is a Phase 3 study that was terminated before completion, run by Romark Laboratories L.C.. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00384527, a Phase 3 study, was terminated before completion, sponsored by Romark Laboratories L.C..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
Interventions
- DRUG Vancomycin
- DRUG Nitazoxanide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2006-12 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
Why NCT00384527 stopped before completion
NCT00384527 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Vancomycin is the first listed.
NCT00384527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00384527 about?
NCT00384527 is a clinical study titled "Study of Nitazoxanide in the Treatment of Clostridium Difficile-associated Disease". The primary objective of the study is to demonstrate non-inferiority of nitazoxanide compared to vancomycin in resolving symptoms of Clostridium difficile-associated disease (CDAD).
What is the current status of trial NCT00384527?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2006-12. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00384527?
The interventions under investigation include: Vancomycin (DRUG), Nitazoxanide (DRUG).
Who is sponsoring clinical trial NCT00384527?
This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00384527's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 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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