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Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis
NCT00417872 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00417872
The ClinicalTrials.gov registry entry for NCT00417872 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Romark Laboratories L.C., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00417872 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Pennsylvania, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00417872?
The interventions under investigation include: Metronidazole (DRUG), Nitazoxanide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00417872?
This trial is sponsored by Romark Laboratories L.C., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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