Status:
COMPLETED
A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C. Difficile-Associated Diarrhea
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Clostridium Enterocolitis
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 symp...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT00196794
Start Date
April 1 2005
End Date
August 1 2007
Last Update
March 19 2014
Active Locations (138)
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1
Adelaide, Australia, 5000
2
Bedford Park, Australia, 5042
3
Cairns, Australia, 4870
4
Concord, Australia, 2139