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

This study has been terminated.

First Received: April 25, 2007 Last Updated: June 18, 2008 History of Changes

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 III

MedlinePlus related topics: Diarrhea

Drug Information available for: Tolevamer Potassium Sodium Potassium chloride

U.S. FDA Resources

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 as provided by Genzyme:

Primary Outcome Measures:

Clinical Success
Safety

Secondary Outcome Measures:

The extent of tolevamer absorption

Estimated Enrollment:	65
Study Start Date:	April 2007
Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466635

Locations

United States, California

Modesto, California, United States
United States, Hawaii

Honolulu, Hawaii, United States
United States, Illinois

Maywood, Illinois, United States
United States, Maryland

Baltimore, Maryland, United States
United States, Massachusetts

Worcester, Massachusetts, United States
United States, Michigan

West Bloomfield, Michigan, United States
United States, Montana

Butte, Montana, United States
United States, New Jersey

Neptune, New Jersey, United States

Cedar Knolls, New Jersey, United States
United States, New York

Syracuse, New York, United States
United States, North Carolina

Greenville, North Carolina, United States
United States, Ohio

Toledo, Ohio, United States
United States, Pennsylvania

Lancaster, Pennsylvania, United States

Sponsors and Collaborators

Genzyme

Investigators

Study Director:

David Davidson, M.D.

Genzyme

More Information

No publications provided

Study ID Numbers:	TOL26700706
Study First Received:	April 25, 2007
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00466635 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genzyme:

Clostridium difficile Disease
Infectious diarrhea
C. difficile
CDAD
Clostridium difficile-associated diarrhea
Clostridium difficile diarrhea

Antibiotic-Associated Colitis
Clostridium Enterocolitis
Antibiotic-Associated Diarrhea
Pseudomembranous Colitis
Clostridium difficile

Study placed in the following topic categories:

Bacterial Infections
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Clostridium Difficile
Enterocolitis, Pseudomembranous
Intestinal Diseases
Enterocolitis

Anti-Bacterial Agents
Signs and Symptoms
Gram-Positive Bacterial Infections
Digestive System Diseases
Dysentery
Gastroenteritis
Clostridium Infections
Colitis

Additional relevant MeSH terms:

Bacterial Infections
Signs and Symptoms
Gram-Positive Bacterial Infections
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Enterocolitis, Pseudomembranous
Clostridium Infections
Intestinal Diseases
Gastroenteritis
Enterocolitis

ClinicalTrials.gov processed this record on May 07, 2009