A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Phase 2

Completed

• Conditions: Pseudomembranous Colitis; Clostridium Difficile Diarrhea; Antibiotic-Associated Diarrhea

• Registration Number: NCT00382304
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that 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 7 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-27
• Study First Submitted QC: 2006-09-27
• Study First Posted: 2006-09-29
• Study Completion: 2007-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 18 years of age or older
• The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea

Exclusion Criteria

• > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
• Patient not considered sufficiently stable clinically to complete the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis

Secondary Outcome Measures

Name	Time	Method
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values