A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in 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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: GT267-004 (tolevamer potassium sodium)
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical Success
- Safety
Secondary Measures
- The extent of tolevamer absorption
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: Genzyme Industry
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Genzyme
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00466635
