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NCT00417872 · ClinicalTrials.gov registry record · Phase 2
Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
A Phase 2 study of Clostridium Difficile, sponsored by Romark Laboratories L.C..
- Completed
- Registry status
- Phase 2
- Development phase
- 114
- Enrollment target
- 7
- Study locations
NCT00417872: Completed Phase 2 study of Clostridium Difficile, sponsored by Romark Laboratories L.C..
NCT00417872 is a Phase 2 study of Clostridium Difficile that has completed, run by Romark Laboratories L.C.. The registered enrollment target is 114 participants, below the 442-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (74% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00417872, a Phase 2 study of Clostridium Difficile, has completed, sponsored by Romark Laboratories L.C..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 114 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times from first dose to last unformed stool and resolution of symptoms of colitis, the sustained response rates for the different tratment groups and the effect of treatment on Clostridium difficile toxin enzyme immunoassay/culture results during hospitalization.
Conditions Studied
Interventions
- DRUG Metronidazole
- DRUG Nitazoxanide
Study Locations (7)
Pennsylvania
- Lehigh Valley Hospital - Allentown
- The Reading Hospital and Medical Center - West Reading
Texas
- Houston Veterans Affairs Hospital - Houston
- St. Luke's Episcopal Hospital - Houston
Florida
- Bayfront Medical Center and Edward White Hospital - St. Petersburg
Georgia
- WellStar Infectious Diseases - Marietta
Ohio
- Remington-Davis, Inc., and Riverside Infection Consultants, Inc. - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-09 |
| Phase | Phase 2 |
What the finished NCT00417872 record still lists
NCT00417872 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, below the 442-participant average among 6 other Clostridium Difficile trials with a reported enrollment target (74% lower).
The record links to 1 condition, with Clostridium Difficile appearing as the primary indexed condition, and to 2 interventions - of which Metronidazole is the first listed.
NCT00417872 lists 7 locations in 5 states (Pennsylvania, Texas, Florida).
Frequently Asked Questions
What is clinical trial NCT00417872 about?
NCT00417872 is a clinical study titled "Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis". The primary objective is to demonstrate non-inferiority of nitazoxanide administered 500 mg b.i.d compared to metronidazole administered 250 mg q.i.d. in resolving symptoms of Clotridium difficile colitis after seven days of treatment. Secondary objectives are to provide information on the times fro...
What is the current status of trial NCT00417872?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 114 participants. The study started on 2004-01. Estimated completion is 2005-09.
What conditions does trial NCT00417872 study?
This clinical trial studies the following conditions: Clostridium Difficile.
What interventions are being tested in trial NCT00417872?
The interventions under investigation include: Metronidazole (DRUG), Nitazoxanide (DRUG).
Who is sponsoring clinical trial NCT00417872?
This trial is sponsored by Romark Laboratories L.C., which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00417872 being conducted?
This trial has 7 study locations across Florida, Georgia, Ohio, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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