Back to resultsA Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Primary Purpose
Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
tolevamer potassium-sodium (GT267-004)
Sponsored by
About this trial
This is an interventional treatment trial for Pseudomembranous Colitis focused on measuring Clostridium difficile-associated diarrhea, C. difficile, CDAD, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Exclusion Criteria:
- > 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
- Patient not considered sufficiently stable clinically to complete the study period
Sites / Locations
Outcomes
Primary Outcome Measures
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Secondary Outcome Measures
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
Full Information
NCT ID
NCT00382304
First Posted
September 27, 2006
Last Updated
March 17, 2015
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT00382304
Brief Title
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Official Title
A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudomembranous Colitis, Clostridium Difficile Diarrhea, Antibiotic-Associated Diarrhea
Keywords
Clostridium difficile-associated diarrhea, C. difficile, CDAD, Clostridium difficile, Clostridium difficile Disease, Clostridium Enterocolitis, Antibiotic-Associated Colitis, Infectious diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tolevamer potassium-sodium (GT267-004)
Primary Outcome Measure Information:
Title
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
Secondary Outcome Measure Information:
Title
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Exclusion Criteria:
> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
Patient not considered sufficiently stable clinically to complete the study period
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
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Nanaimo
State/Province
British Columbia
ZIP/Postal Code
V9S 2B7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V3Z 1M9
Country
Canada
City
Ottowa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 4Z3
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
We'll reach out to this number within 24 hrs