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A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106509
First Posted: March 28, 2005
Last Update Posted: March 5, 2015
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.
Information provided by:
Sanofi
  Purpose
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. 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 6 weeks.

Condition Intervention Phase
Clostridium Enterocolitis Pseudomembranous Colitis Drug: tolevamer potassium-sodium (GT267-004) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Resolution of diarrhea

Secondary Outcome Measures:
  • Time to resolution of diarrhea
  • Recurrence rate
  • Number of stools
  • Average stool consistency
  • Treatment success

Estimated Enrollment: 520
Study Start Date: March 2005
Study Completion Date: February 2007
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age
  • The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
  • Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
  • Baseline serum potassium > 3.0 mmol (meq)/L
  • Patient considered sufficiently stable clinically to likely complete a 6 week study period
  Contacts and Locations
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): NCT00106509


  Show 140 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00106509     History of Changes
Other Study ID Numbers: GD3-170-301
First Submitted: March 25, 2005
First Posted: March 28, 2005
Last Update Posted: March 5, 2015
Last Verified: March 2015

Keywords provided by Sanofi:
Clostridium Enterocolitis
Pseudomembranous Colitis
Clostridium difficile-associated diarrhea
C. difficile
CDAD

Additional relevant MeSH terms:
Colitis
Diarrhea
Enterocolitis
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
Metronidazole
Vancomycin
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents