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

Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00466635
• Other study ID #: TOL26700706
• Status: Terminated
• Phase: Phase 3
• First received: April 25, 2007
• Last updated: March 17, 2015
• Start date: April 2007
• Est. completion date: August 2007

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile
• Diarrhea
• Enterocolitis
• Enterocolitis, Pseudomembranous

Intervention

Drug:
• GT267-004 (tolevamer potassium sodium)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Success
Primary	Safety
Secondary	The extent of tolevamer absorption