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

Conditions

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Nanaimo, British Columbia, Canada, V9S 2B7
      • Vancouver, British Columbia, Canada, V3Z 1M9
    • Ontario
      • Ottowa, Ontario, Canada, K1H 8L6
      • Richmond Hill, Ontario, Canada, L4C 4Z3
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
      • Rimouski, Quebec, Canada, G5L 5T1
      • Sherbrooke, Quebec, Canada, J1H 5N4

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
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis

Secondary Outcome Measures

Outcome Measure
Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

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

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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