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

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...

Date First Received: September 13, 2005

Last Updated: August 17, 2007

Verified by: Genzyme, May 2007

Clinical Trial Phase: Phase 3 | Start Date: April 2005

Overall Status: Completed

Estimated Enrollment: 520

Brief Summary

Official Title: “A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea”

Condition Keyword(s):

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Tolevamer potassium-sodium (GT267-004)

Outcome Measures for this Clinical Trial

Primary Measures

  • Resolution of diarrhea

Secondary Measures

  • Time to resolution of diarrhea
  • Recurrence rate
  • Number of stools
  • Average stool consistency
  • Treatment success

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Genzyme

Overall Clinical Trial Officials and Contacts

David Davidson, M.D. Study Director Genzyme  

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00196794

Study ID Number: GD3-170-302

ClinicalTrials.gov Identifier: NCT00196794

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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