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A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: April 24, 2002
Last updated: March 4, 2015
Last verified: March 2015

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.

All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.

Condition Intervention Phase
Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-associated Colitis
Antibiotic-associated Diarrhea
Drug: GT160-246
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Resource links provided by NLM:

Further study details as provided by Sanofi:

Estimated Enrollment: 300
Study Start Date: February 2002
Study Completion Date: July 2003

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be at least 18 years old.
  • Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
  • Be able to tolerate oral medication.
  • Not be pregnant or breast-feeding.
  • Sign and date an informed consent form.
  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 identifier: NCT00034294

  Show 99 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company Identifier: NCT00034294     History of Changes
Other Study ID Numbers: GTC-80-203  GT1105 
Study First Received: April 24, 2002
Last Updated: March 4, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
C. difficile-associated diarrhea
Clostridium difficile-Associated Diarrhea
Clostridium enterocolitis
antibiotic-associated diarrhea
clostridium difficile colitis
infectious diarrhea
chronic diarrhea
antibiotic-associated colitis

Additional relevant MeSH terms:
Enterocolitis, Pseudomembranous
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents processed this record on October 26, 2016