- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00382304
A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
March 17, 2015 updated by: Genzyme, a Sanofi Company
A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
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British Columbia
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Nanaimo, British Columbia, Canada, V9S 2B7
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Vancouver, British Columbia, Canada, V3Z 1M9
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Ontario
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Ottowa, Ontario, Canada, K1H 8L6
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Richmond Hill, Ontario, Canada, L4C 4Z3
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Quebec
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Montreal, Quebec, Canada, H3T 1E2
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Rimouski, Quebec, Canada, G5L 5T1
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Sherbrooke, Quebec, Canada, J1H 5N4
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
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Secondary Outcome Measures
Outcome Measure |
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Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
September 27, 2006
First Submitted That Met QC Criteria
September 27, 2006
First Posted (Estimate)
September 29, 2006
Study Record Updates
Last Update Posted (Estimate)
March 19, 2015
Last Update Submitted That Met QC Criteria
March 17, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Enterocolitis
- Diarrhea
- Colitis
- Clostridium Infections
- Enterocolitis, Pseudomembranous
Other Study ID Numbers
- TOL26700606
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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