A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

This study has been completed.

Sponsor:

Information provided by:

Genzyme

ClinicalTrials.gov Identifier:

NCT00106509

First received: March 25, 2005

Last updated: July 29, 2009

Last verified: April 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 25, 2005

Last Updated Date

July 29, 2009

Start Date ^ICMJE

March 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Resolution of diarrhea

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00106509 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time to resolution of diarrhea
Recurrence rate
Number of stools
Average stool consistency
Treatment success

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Study of GT267-004 Versus Vancomycin and GT267-004 Versus Metronidazole in Patients With C.Difficile - Associated Diarrhea

Official Title ^ICMJE

A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea

Brief Summary

Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. 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 6 weeks.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Clostridium Enterocolitis
Pseudomembranous Colitis

Intervention ^ICMJE

Drug: tolevamer potassium-sodium (GT267-004)

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

520

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age
The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
Baseline serum potassium > 3.0 mmol (meq)/L
Patient considered sufficiently stable clinically to likely complete a 6 week study period

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

Administrative Information

NCT Number ^ICMJE

NCT00106509

Other Study ID Numbers ^ICMJE

GD3-170-301

Has Data Monitoring Committee

Responsible Party

Medical Monitor, Genzyme Corporation

Study Sponsor ^ICMJE

Genzyme

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Genzyme

Information Provided By

Genzyme

Verification Date

April 2007

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

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