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:
Sanofi
ClinicalTrials.gov Identifier:
NCT00196794
First received: September 13, 2005
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

Approximately 520 patients will be entered into this study taking place throughout Australia and Europe. 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. The total length of participation is approximately 6 weeks.


Condition Intervention Phase
Clostridium Enterocolitis
Diarrhea
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:


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

Enrollment: 520
Study Start Date: April 2005
Study Completion Date: August 2007
  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 and above
  • 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 6 week study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196794

  Show 138 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme Corporation
ClinicalTrials.gov Identifier: NCT00196794     History of Changes
Other Study ID Numbers: GD3-170-302
Study First Received: September 13, 2005
Last Updated: March 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration

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

Additional relevant MeSH terms:
Diarrhea
Enterocolitis
Enterocolitis, Pseudomembranous
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
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 April 17, 2014