A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00382304
First received: September 27, 2006
Last updated: August 3, 2009
Last verified: December 2007
  Purpose

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.


Condition Intervention Phase
Pseudomembranous Colitis
Clostridium Difficile Diarrhea
Antibiotic-Associated Diarrhea
Drug: tolevamer potassium-sodium (GT267-004)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of the Pharmacokinetics of GT267-004 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:
  • The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis

Secondary Outcome Measures:
  • Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values

Estimated Enrollment: 24
Study Start Date: September 2006
Study Completion Date: September 2007
  Eligibility

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

Inclusion Criteria:

  • 18 years of age or older
  • The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria:

  • > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
  • Patient not considered sufficiently stable clinically to complete the study period
  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: NCT00382304

Locations
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Nanaimo, British Columbia, Canada, V9S 2B7
Vancouver, British Columbia, Canada, V3Z 1M9
Canada, Ontario
Ottowa, Ontario, Canada, K1H 8L6
Richmond Hill, Ontario, Canada, L4C 4Z3
Canada, Quebec
Montreal, Quebec, Canada, H3T 1E2
Rimouski, Quebec, Canada, G5L 5T1
Sherbrooke, Quebec, Canada, J1H 5N4
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: NCT00382304     History of Changes
Other Study ID Numbers: TOL26700606
Study First Received: September 27, 2006
Last Updated: August 3, 2009
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Genzyme, a Sanofi Company:
Clostridium difficile-associated diarrhea
C. difficile
CDAD
Clostridium difficile
Clostridium difficile Disease
Clostridium Enterocolitis
Antibiotic-Associated Colitis
Infectious diarrhea

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

ClinicalTrials.gov processed this record on July 29, 2014