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

Phase 2

Completed

• Conditions: Clostridium Difficile-Associated Diarrhea; Clostridium Difficile Diarrhea; Clostridium Enterocolitis; Antibiotic-associated Diarrhea; Antibiotic-associated Colitis

• Registration Number: NCT00034294
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Study First Submitted: 2002-04-24
• Study First Submitted QC: 2002-04-24
• Study First Posted: 2002-04-25
• Study Completion: 2003-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL