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

March 17, 2015 updated by: Genzyme, a Sanofi Company

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Modesto, California, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Maywood, Illinois, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • West Bloomfield, Michigan, United States
    • Montana
      • Butte, Montana, United States
    • New Jersey
      • Cedar Knolls, New Jersey, United States
      • Neptune, New Jersey, United States
    • New York
      • Syracuse, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
    • Ohio
      • Toledo, Ohio, United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The presence of CDAD at the time of enrollment
  • Negative serum pregnancy test (HCG) for women of childbearing potential.

Exclusion Criteria:

  • Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
  • Any acutely life-threatening medical conditions.
  • Acute or chronic diarrhea of other cause.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Clinical Success

Secondary Outcome Measures

Outcome Measure
The extent of tolevamer absorption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 25, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TOL26700706

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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