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

This study has been terminated.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00466635
First received: April 25, 2007
Last updated: August 3, 2009
Last verified: September 2007
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cedar Knolls, New Jersey, United States
Neptune, 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, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00466635     History of Changes
Other Study ID Numbers: TOL26700706
Study First Received: April 25, 2007
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
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

Additional relevant MeSH terms:
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 18, 2014