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

March 4, 2015 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

520

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T5H 3V9
    • British Columbia
      • Kelowna, British Columbia, Canada, V1V 1Y5
      • Kelowna, British Columbia, Canada, V1Y 1T2 & V1Y3G8
      • Vancouver, British Columbia, Canada, V5Z 3J5
      • Victoria, British Columbia, Canada, V8R 1J8
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
      • Winnipeg, Manitoba, Canada, R3C 0N2
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
      • Saint John, New Brunswick, Canada, E2K 4L2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
      • Guelph, Ontario, Canada, N1E 4J4
      • Hamilton, Ontario, Canada, L8N 4A6
      • Kingston, Ontario, Canada, K7L 3N6
      • London, Ontario, Canada, N6A 4G5
      • Ottawa, Ontario, Canada, K1H 8L6
      • Peterborough, Ontario, Canada, K9J 7B3
      • Scarborough, Ontario, Canada, M1E 4B9
      • Thunder Bay, Ontario, Canada, P7B 6V1
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M2K 1E1
      • Toronto, Ontario, Canada, M3N 2V6
      • Toronto, Ontario, Canada, M5G 2M9 & M5G 1X5
      • Windsor, Ontario, Canada, N9A 1E1
      • Windsor, Ontario, Canada, N8X 3V6
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Green Field Park, Quebec, Canada, J4V 2H1
      • Levis, Quebec, Canada, G6V 3Z1
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H3G 1A4
      • Quebec City, Quebec, Canada, G1R 2J6
      • Quebec City, Quebec, Canada, G1L 3L5
      • Sainte Foy, Quebec, Canada, G1V 4G2
      • St-Hyacinthe, Quebec, Canada, J2S 4Y8
      • St. Charles Borromee, Quebec, Canada, J6E 2C3
      • Trois Rivieres, Quebec, Canada, G9A 1Y1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1J5
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85012
      • Phoenix, Arizona, United States, 85006
    • Arkansas
      • Rogers, Arkansas, United States, 72756
    • California
      • Burbank, California, United States, 91505
      • Los Angeles, California, United States, 90073
      • Los Angeles, California, United States, 90089
      • Los Angeles, California, United States, 90095
      • Modesto, California, United States, 95350
      • Newport Beach, California, United States, 92663
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92103
    • Colorado
      • Denver, Colorado, United States, 80204
      • Denver, Colorado, United States, 80262
      • Denver, Colorado, United States, 80210
      • Denver, Colorado, United States, 80218-1191
    • Delaware
      • Newark, Delaware, United States, 19718
    • Florida
      • Bay Pines, Florida, United States, 33744
      • Brandon, Florida, United States, 33511
      • Brooksville, Florida, United States, 34613
      • Jacksonville, Florida, United States, 32207
      • Tampa, Florida, United States, 33607
      • Zephyrhills, Florida, United States, 33542
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Ft. Gordon, Georgia, United States, 30905
      • Savannah, Georgia, United States, 31405
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Chicago, Illinois, United States, 60634
      • Decatur, Illinois, United States, 62526
      • Hines, Illinois, United States, 60141
      • Maywood, Illinois, United States, 60153
      • North Chicago, Illinois, United States, 60064
    • Indiana
      • Anderson, Indiana, United States, 46011
      • Indianapolis, Indiana, United States, 46202
      • Lafayette, Indiana, United States, 47904
      • Muncie, Indiana, United States, 47303
    • Iowa
      • Clive, Iowa, United States, 50325
      • Des Moines, Iowa, United States, 50309
      • Des Moines, Iowa, United States, 50302
      • Dubuque, Iowa, United States, 52002
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40206-1499
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
      • New Orleans, Louisiana, United States, 70115
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Hagerstown, Maryland, United States, 21740
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
      • Boston, Massachusetts, United States, 02115
      • Worcester, Massachusetts, United States, 01655
      • Worcester, Massachusetts, United States, 01608-1320
    • Michigan
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
      • Muskegon, Michigan, United States, 49444
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Mississippi
      • Ocean Springs, Mississippi, United States, 39564
    • Missouri
      • Everton, Missouri, United States, 65646
      • Kansas City, Missouri, United States, 64111
      • St. Louis, Missouri, United States, 63110
    • Montana
      • Butte, Montana, United States, 59701
      • Missoula, Montana, United States, 59802
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
      • Neptune, New Jersey, United States, 07753
      • Newark, New Jersey, United States, 07103
      • Trenton, New Jersey, United States, 08629
    • New York
      • Albany, New York, United States, 12208
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10016
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Greenville, North Carolina, United States, 27834
      • Raleigh, North Carolina, United States, 27612
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Akron, Ohio, United States, 44304
      • Centerville, Ohio, United States, 45459
      • Toledo, Ohio, United States, 43608
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18102
      • Doylestown, Pennsylvania, United States, 18901
      • Lancaster, Pennsylvania, United States, 17602
      • Philadelphia, Pennsylvania, United States, 19141
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15261
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29401
      • Greenville, South Carolina, United States, 29605
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Hermitage, Tennessee, United States, 37076
    • Texas
      • Houston, Texas, United States, 77030
      • Tyler, Texas, United States, 75702
    • Vermont
      • Burlington, Vermont, United States, 05403
    • Virginia
      • Danville, Virginia, United States, 24541
      • Richmond, Virginia, United States, 23298
      • Richmond, Virginia, United States, 23249
      • Winchester, Virginia, United States, 22601
    • Washington
      • Tacoma, Washington, United States, 98431
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54710
      • Marshfield, Wisconsin, United States, 54449
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Resolution of diarrhea

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

March 25, 2005

First Submitted That Met QC Criteria

March 25, 2005

First Posted (Estimate)

March 28, 2005

Study Record Updates

Last Update Posted (Estimate)

March 5, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GD3-170-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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