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

Sponsor

Genzyme, a Sanofi Company (Industry)

Overall Status

Terminated

CT.gov ID

NCT00466635

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enterocolitis, Pseudomembranous Diarrhea Clostridium Difficile	Drug: GT267-004 (tolevamer potassium sodium)	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

65 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Clinical Success []
Safety []

Secondary Outcome Measures

The extent of tolevamer absorption []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Modesto	California	United States
2	Honolulu	Hawaii	United States
3	Maywood	Illinois	United States
4	Baltimore	Maryland	United States
5	Worcester	Massachusetts	United States
6	West Bloomfield	Michigan	United States
7	Butte	Montana	United States
8	Cedar Knolls	New Jersey	United States
9	Neptune	New Jersey	United States
10	Syracuse	New York	United States
11	Greenville	North Carolina	United States
12	Toledo	Ohio	United States
13	Lancaster	Pennsylvania	United States