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

Last updated: March 4, 2015
Sponsor: Genzyme, a Sanofi Company
Overall Status: Completed

Phase

3

Condition

Hyponatremia

Colic

Clostridium Difficile-associated Diarrhea

Treatment

N/A

Clinical Study ID

NCT00106509
GD3-170-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 520
Study Start date:
March 01, 2005
Estimated Completion Date:
February 28, 2007

Connect with a study center

  • Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • Kelowna, British Columbia V1V 1Y5
    Canada

    Site Not Available

  • Vancouver, British Columbia V5Z 3J5
    Canada

    Site Not Available

  • Victoria, British Columbia V8R 1J8
    Canada

    Site Not Available

  • Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Moncton, New Brunswick E1C 6Z8
    Canada

    Site Not Available

  • Saint John, New Brunswick E2K 4L2
    Canada

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  • Halifax, Nova Scotia B3H 2Y9
    Canada

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  • Ajax, Ontario L1S 2J5
    Canada

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  • Guelph, Ontario N1E 4J4
    Canada

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  • Hamilton, Ontario L8N 4A6
    Canada

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  • Kingston, Ontario K7L 3N6
    Canada

    Site Not Available

  • London, Ontario N6A 4G5
    Canada

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  • Ottawa, Ontario K1H 8L6
    Canada

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  • Peterborough, Ontario K9J 7B3
    Canada

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  • Scarborough, Ontario M1E 4B9
    Canada

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  • Thunder Bay, Ontario P7B 6V1
    Canada

    Site Not Available

  • Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Windsor, Ontario N8X 3V6
    Canada

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  • Chicoutimi, Quebec G7H 5H6
    Canada

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  • Green Field Park, Quebec J4V 2H1
    Canada

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  • Levis, Quebec G6V 3Z1
    Canada

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  • Montreal, Quebec H3G 1A4
    Canada

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  • Quebec City, Quebec G1R 2J6
    Canada

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  • Sainte Foy, Quebec G1V 4G2
    Canada

    Site Not Available

  • St-Hyacinthe, Quebec J2S 4Y8
    Canada

    Site Not Available

  • St. Charles Borromee, Quebec J6E 2C3
    Canada

    Site Not Available

  • Trois Rivieres, Quebec G9A 1Y1
    Canada

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  • Saskatoon, Saskatchewan S7K 1J5
    Canada

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  • San Juan, 00935
    Puerto Rico

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  • Phoenix, Arizona 85012
    United States

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  • Rogers, Arkansas 72756
    United States

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  • Burbank, California 91505
    United States

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  • Los Angeles, California 90089
    United States

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  • Modesto, California 95350
    United States

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  • Newport Beach, California 92663
    United States

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  • Sacramento, California 95817
    United States

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  • San Diego, California 92103
    United States

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  • Denver, Colorado 80210
    United States

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  • Bay Pines, Florida 33744
    United States

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  • Brandon, Florida 33511
    United States

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  • Brooksville, Florida 34613
    United States

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  • Jacksonville, Florida 32207
    United States

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  • Tampa, Florida 33607
    United States

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  • Zephyrhills, Florida 33542
    United States

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  • Atlanta, Georgia 30309
    United States

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  • Ft. Gordon, Georgia 30905
    United States

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  • Savannah, Georgia 31405
    United States

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  • Honolulu, Hawaii 96813
    United States

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  • Chicago, Illinois 60634
    United States

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  • Decatur, Illinois 62526
    United States

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  • Hines, Illinois 60141
    United States

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  • Maywood, Illinois 60153
    United States

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  • North Chicago, Illinois 60064
    United States

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  • Anderson, Indiana 46011
    United States

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  • Indianapolis, Indiana 46202
    United States

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  • Lafayette, Indiana 47904
    United States

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  • Muncie, Indiana 47303
    United States

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  • Clive, Iowa 50325
    United States

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  • Des Moines, Iowa 50302
    United States

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  • Dubuque, Iowa 52002
    United States

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  • Iowa City, Iowa 52242
    United States

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  • Bowling Green, Kentucky 42101
    United States

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  • Louisville, Kentucky 40206-1499
    United States

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  • New Orleans, Louisiana 70115
    United States

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  • Baltimore, Maryland 21201
    United States

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  • Hagerstown, Maryland 21740
    United States

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  • Boston, Massachusetts 02115
    United States

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  • Worcester, Massachusetts 01655
    United States

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  • Detroit, Michigan 48201
    United States

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  • Muskegon, Michigan 49444
    United States

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  • Rochester, Minnesota 55905
    United States

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  • Ocean Springs, Mississippi 39564
    United States

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  • Everton, Missouri 65646
    United States

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  • Kansas City, Missouri 64111
    United States

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  • St. Louis, Missouri 63110
    United States

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  • Butte, Montana 59701
    United States

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  • Missoula, Montana 59802
    United States

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  • Lebanon, New Hampshire 03756
    United States

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  • Cedar Knolls, New Jersey 07927
    United States

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  • Neptune, New Jersey 07753
    United States

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  • Newark, New Jersey 07103
    United States

    Site Not Available

  • Trenton, New Jersey 08629
    United States

    Site Not Available

  • Albany, New York 12208
    United States

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  • New Hyde Park, New York 11040
    United States

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  • New York, New York 10016
    United States

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  • Syracuse, New York 13210
    United States

    Site Not Available

  • Asheville, North Carolina 28801
    United States

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  • Raleigh, North Carolina 27612
    United States

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  • Fargo, North Dakota 58122
    United States

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  • Akron, Ohio 44304
    United States

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  • Centerville, Ohio 45459
    United States

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  • Toledo, Ohio 43608
    United States

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  • Allentown, Pennsylvania 18102
    United States

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  • Doylestown, Pennsylvania 18901
    United States

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  • Lancaster, Pennsylvania 17602
    United States

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  • Philadelphia, Pennsylvania 19140
    United States

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  • Pittsburgh, Pennsylvania 15261
    United States

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  • Charleston, South Carolina 29401
    United States

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  • Greenville, South Carolina 29605
    United States

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  • Rapid City, South Dakota 57701
    United States

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  • Hermitage, Tennessee 37076
    United States

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  • Houston, Texas 77030
    United States

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  • Tyler, Texas 75702
    United States

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  • Burlington, Vermont 05403
    United States

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  • Danville, Virginia 24541
    United States

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  • Richmond, Virginia 23249
    United States

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  • Winchester, Virginia 22601
    United States

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  • Tacoma, Washington 98431
    United States

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  • Eau Claire, Wisconsin 54710
    United States

    Site Not Available

  • Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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