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

Tracking Information

First Received Date ^ICMJE

April 24, 2002

Last Updated Date

July 29, 2009

Start Date ^ICMJE

February 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00034294 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Clostridium Difficile-Associated Diarrhea
Clostridium Enterocolitis
Clostridium Difficile Diarrhea
Antibiotic-Associated Colitis
Antibiotic-Associated Diarrhea

Intervention ^ICMJE

Drug: GT160-246

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada, Puerto Rico, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00034294

Responsible Party

Medical Monitor, Genzyme Corporation

Study ID Numbers ^ICMJE

GTC-80-203, GT1105

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP