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

Stopped early · Phase 3

Conditions studied: Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile

In brief

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.

Key facts

Study ID

NCT00466635

Run by

Genzyme, a Sanofi Company

People needed

65

Starts

2007-04-01

Expected to finish

2007-08-01

Last updated by the study team

2015-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Study site — Modesto, California, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Maywood, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — West Bloomfield, Michigan, United States
• Study site — Butte, Montana, United States
• Study site — Cedar Knolls, New Jersey, United States
• Study site — Neptune City, New Jersey, United States
• Study site — Syracuse, New York, United States
• Study site — Greenville, North Carolina, United States
• Study site — Toledo, Ohio, United States
• Study site — Lancaster, Pennsylvania, United States

Full record on ClinicalTrials.gov

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