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NCT00034294 Clinical Trial

A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Antibiotic-associated Diarrhea Clinical Trial

Official title:
A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00034294
Other study ID # GTC-80-203
Secondary ID GT1105
Status Completed
Phase Phase 2
First received April 24, 2002
Last updated March 4, 2015
Start date February 2002
Est. completion date July 2003

Study information
Verified date March 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. 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 10 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Be at least 18 years old.

- Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).

- Be able to tolerate oral medication.

- Not be pregnant or breast-feeding.

- Sign and date an informed consent form.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• GT160-246

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico,  United Kingdom, 

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