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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00034294
First received: April 24, 2002
Last updated: July 29, 2009
Last verified: November 2006

April 24, 2002
July 29, 2009
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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Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.
 
Completed
300
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   Canada,   Puerto Rico
 
NCT00034294
GTC-80-203, GT1105
Not Provided
Medical Monitor, Genzyme Corporation
Genzyme, a Sanofi Company
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Study Director: Medical Monitor Genzyme, a Sanofi Company
Genzyme, a Sanofi Company
November 2006

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