Back to resultsA Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
Primary Purpose
Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GT267-004 (tolevamer potassium sodium)
Sponsored by
About this trial
This is an interventional treatment trial for Enterocolitis, Pseudomembranous focused on measuring Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Clostridium difficile
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Clinical Success
Safety
Secondary Outcome Measures
The extent of tolevamer absorption
Full Information
NCT ID
NCT00466635
First Posted
April 25, 2007
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00466635
Brief Title
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
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 Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
April 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterocolitis, Pseudomembranous, Diarrhea, Clostridium Difficile
Keywords
Clostridium difficile Disease, Infectious diarrhea, C. difficile, CDAD, Clostridium difficile-associated diarrhea, Clostridium difficile diarrhea, Antibiotic-Associated Colitis, Clostridium Enterocolitis, Antibiotic-Associated Diarrhea, Pseudomembranous Colitis, Clostridium difficile
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GT267-004 (tolevamer potassium sodium)
Primary Outcome Measure Information:
Title
Clinical Success
Title
Safety
Secondary Outcome Measure Information:
Title
The extent of tolevamer absorption
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Genzyme, a Sanofi Company
Official's Role
Study Director
Facility Information:
City
Modesto
State/Province
California
Country
United States
City
Honolulu
State/Province
Hawaii
Country
United States
City
Maywood
State/Province
Illinois
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
West Bloomfield
State/Province
Michigan
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Cedar Knolls
State/Province
New Jersey
Country
United States
City
Neptune
State/Province
New Jersey
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Lancaster
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Safety, Tolerability, Effectiveness and Absorption of Exodif™ Tablets in Clostridium Difficile-associated Diarrhea
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