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Completed Phase 2 Interventional

Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

ClinicalTrials.gov ID: NCT00417872

Public ClinicalTrials.gov record NCT00417872. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 1:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Multicenter, Double Blind, Metronidazole Controlled, Dose Range Finding Study of Nitazoxanide in the Treatment of Clostridium Difficile Colitis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00417872
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Romark Laboratories L.C.
Industry
Enrollment
114 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2003
Primary completion
Not listed
Completion
Aug 31, 2005
Last update posted
Jan 3, 2007

2004 – 2005

United States locations

U.S. sites
7
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Bayfront Medical Center and Edward White Hospital St. Petersburg Florida 33713
WellStar Infectious Diseases Marietta Georgia 30060
Remington-Davis, Inc., and Riverside Infection Consultants, Inc. Columbus Ohio 43214
Lehigh Valley Hospital Allentown Pennsylvania 18103
The Reading Hospital and Medical Center West Reading Pennsylvania 19611
Houston Veterans Affairs Hospital Houston Texas 77030
St. Luke's Episcopal Hospital Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00417872, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 3, 2007 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00417872 live on ClinicalTrials.gov.

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