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

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ClinicalTrials.gov Identifier: NCT00466635
Recruitment Status : Terminated
First Posted : April 27, 2007
Last Update Posted : March 19, 2015
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Enterocolitis, Pseudomembranous Diarrhea Clostridium Difficile Drug: GT267-004 (tolevamer potassium sodium) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea Potassium
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical Success
  2. Safety

Secondary Outcome Measures :
  1. The extent of tolevamer absorption


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00466635     History of Changes
Other Study ID Numbers: TOL26700706
First Posted: April 27, 2007    Key Record Dates
Last Update Posted: March 19, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
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