A Study of the Absorption of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea

Genzyme, a Sanofi Company24 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pseudomembranous Colitis Clostridium Difficile Diarrhea Antibiotic-Associated Diarrhea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Edmonton, Alberta, Canada

Unnamed facility

Nanaimo, British Columbia, Canada

Unnamed facility

Vancouver, British Columbia, Canada

Unnamed facility

Ottowa, Ontario, Canada

Unnamed facility

Richmond Hill, Ontario, Canada

Unnamed facility

Montreal, Quebec, Canada

Unnamed facility

Rimouski, Quebec, Canada

Unnamed facility

Sherbrooke, Quebec, Canada

Outcomes

Primary Outcomes

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

Secondary Outcomes

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