A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea

Phase 3

Terminated

• Conditions: Enterocolitis, Pseudomembranous; Diarrhea; Clostridium Difficile

• Registration Number: NCT00466635
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-26
• Study First Posted: 2007-04-27
• Study Completion: 2007-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• The presence of CDAD at the time of enrollment
• Negative serum pregnancy test (HCG) for women of childbearing potential.

Exclusion Criteria

• Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
• Any acutely life-threatening medical conditions.
• Acute or chronic diarrhea of other cause.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Clinical Success

Secondary Outcome Measures

Name	Time	Method
The extent of tolevamer absorption