A Study of the Absorption 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.

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Key information

Conditions

Pseudomembranous Colitis Antibiotic-associated Diarrhea Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Diarrhea Clostridium Infections Digestive System Diseases Dysentery Enterocolitis Enterocolitis, Pseudomembranous Gastroenteritis Gastrointestinal Diseases Gram-Positive Bacterial Infections Infections Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Edmonton, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tolevamer potassium-sodium (GT267-004)

Drug

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

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Study completion: 2007
First posted: Sep 29, 2006
Registry last updated: Mar 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed