TOL26700706: A Study to Look at the Safety, Tolerability, Effectiveness and Absorption (How the Drug is Taken up) of a Newly Developed Medication Called Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea

This study has been terminated.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00466635

Purpose

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.

Condition	Intervention	Phase
Enterocolitis, Pseudomembranous Diarrhea Clostridium Difficile	Drug: GT267-004 (tolevamer potassium sodium)	Phase 3

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

Further Study Details:

Primary Outcome Measures: Clinical Success, Safety

Secondary Outcome Measures: The extent of tolevamer absorption

Expected Total Enrollment: 65

Study Start: 2007-04; Study Completion: 2007-08

Eligibility

Ages Eligible for Study: 18 Years and above

Genders Eligible for Study: Both

Criteria

Inclusion Criteria:

The presence of CDAD at the time of enrollment Negative serum pregnancy test (HCG) for women of childbearing potential. Committed to follow all protocol-required study procedures as evidenced by providing written informed consent within 14 days prior to Visit 1.

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.

Location and Contact Information

Central Contact:
Medical Information 800-745-4447 medinfo@genzyme.com
Medical Information 617-252-7832 medinfo@genzyme.com

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
Detroit, Michigan, United States

Montana
Butte, Montana, United States

New Jersey
Neptune, New Jersey, United States
Cedar Knolls, 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

More Information

Study ID Numbers: TOL26700706
ClinicalTrials.gov Identifier: NCT00466635
Health Authority: United States: Food and Drug Administration