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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00034294
Recruitment Status : Completed
First Posted : April 25, 2002
Last Update Posted : March 5, 2015
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

April 24, 2002
April 25, 2002
March 5, 2015
February 2002
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Complete list of historical versions of study NCT00034294 on ClinicalTrials.gov Archive Site
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A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

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.

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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Clostridium Difficile-Associated Diarrhea
  • Clostridium Enterocolitis
  • Clostridium Difficile Diarrhea
  • Antibiotic-associated Colitis
  • Antibiotic-associated Diarrhea
Drug: GT160-246
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2003
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   Puerto Rico,   United Kingdom,   United States
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Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP