A Study of GT160-246 Versus Vancomycin in Patients With Clostridium Difficile-Associated Diarrhea

Approximately 300 patients will be entered into this study taking place throughout the United States, Canada and the United Kingdom. This study aims to determine if an investigational drug is safe and effective for treating the symptoms of C. difficile-associated diarrhea and lowering the risk of repeat episodes of diarrhea. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication.

All study-related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 10 weeks.

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Key information

Conditions

Clostridium Difficile-associated Diarrhea Antibiotic-Associated Colitis Antibiotic-associated Diarrhea Bacterial Infections Bacterial Infections and Mycoses Clostridium Difficile Diarrhea Clostridium Enterocolitis 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

Calgary, Alberta, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Be at least 18 years old.
Have active mild to moderate C. difficile- Associated Diarrhea (CDAD).
Be able to tolerate oral medication.
Not be pregnant or breast-feeding.
Sign and date an informed consent form.

Treatment and study plan

GT160-246

Drug

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

A Randomized, Double-Blind Study of GT160-246 Versus Vancomycin in Patients With C. Difficile-Associated Diarrhea

Important dates

Study start: 2002
Study completion: 2003
First posted: Apr 25, 2002
Registry last updated: Mar 5, 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