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Terminated Phase 3 Interventional

A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

ClinicalTrials.gov ID: NCT00466635

Public ClinicalTrials.gov record NCT00466635. 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 Oct 23, 2026, 12:39 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

An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea

Brief summary

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

Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Study identification

NCT ID
NCT00466635
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
65 participants

Conditions and interventions

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
Apr 2007 (Type not available)
Primary completion
Not listed
Completion
Aug 2007 (Actual)
Last update posted
Mar 19, 2015

2007

United States locations

U.S. sites
13
U.S. states
12
U.S. cities
13
Facility City State ZIP Site status
Not listed Modesto California — —
Not listed Honolulu Hawaii — —
Not listed Maywood Illinois — —
Not listed Baltimore Maryland — —
Not listed Worcester Massachusetts — —
Not listed West Bloomfield Michigan — —
Not listed Butte Montana — —
Not listed Cedar Knolls New Jersey — —
Not listed Neptune City New Jersey — —
Not listed Syracuse New York — —
Not listed Greenville North Carolina — —
Not listed Toledo Ohio — —
Not listed Lancaster Pennsylvania — —

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 NCT00466635, 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 Mar 19, 2015 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00466635 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →