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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:
Information provided by:
Genzyme
ClinicalTrials.gov Identifier:
NCT00106509
First received: March 25, 2005
Last updated: July 29, 2009
Last verified: April 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Diarrhea Potassium
U.S. FDA Resources

Further study details as provided by Genzyme:

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
  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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106509

  Show 140 Study Locations
Sponsors and Collaborators
Genzyme
Investigators
Study Director: Medical Monitor Genzyme
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00106509     History of Changes
Other Study ID Numbers: GD3-170-301
Study First Received: March 25, 2005
Last Updated: July 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Genzyme:
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
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Antiprotozoal Agents
Antiparasitic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 18, 2013