Official Title: “An Open-Label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: GT267-004 (tolevamer potassium sodium)

Primary Measures

• Clinical Success
• Safety

Secondary Measures

• The extent of tolevamer absorption

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Genzyme

Overall Clinical Trial Officials and Contacts

David Davidson, M.D. Study Director Genzyme  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00466635

Study ID Number: TOL26700706

ClinicalTrials.gov Identifier: NCT00466635

Health Authority: United States: Food and Drug Administration