Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

Last updated: April 15, 2015
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Gastroparesis

Functional Dyspepsia

Irritable Bowel Syndrome (Ibs- Pediatric)

Treatment

N/A

Clinical Study ID

NCT00067561
S3B30040
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).

  • Failed conventional therapy.

  • Willing to make daily calls on a touch-tone telephone.

Exclusion

Exclusion criteria:

  • History of or current chronic or severe constipation.

  • Bloody diarrhea, abdominal pain with rectal bleeding.

  • Thrombophlebitis.

  • Abnormal thyroid stimulating hormone (TSH) value.

  • Alcohol and/or substance abuse within past two years.

  • Pregnant or lactating.

  • History/treatment of malignancy within past five years.

Study Design

Total Participants: 702
Study Start date:
June 01, 2003
Estimated Completion Date:
January 31, 2005

Connect with a study center

  • GSK Investigational Site

    Nedlands, Western Australia 27408
    Australia

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35235
    United States

    Site Not Available

  • GSK Investigational Site

    Calera, Alabama 35040
    United States

    Site Not Available

  • GSK Investigational Site

    Tuscaloosa, Alabama 35406
    United States

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85723
    United States

    Site Not Available

  • GSK Investigational Site

    Chula Vista, California 91910
    United States

    Site Not Available

  • GSK Investigational Site

    Fountain Valley, California 92708
    United States

    Site Not Available

  • GSK Investigational Site

    Garden Grove, California 92840
    United States

    Site Not Available

  • GSK Investigational Site

    Lancaster, California 93534
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90045
    United States

    Site Not Available

  • GSK Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • GSK Investigational Site

    Rancho Cucamonga, California 91730
    United States

    Site Not Available

  • GSK Investigational Site

    Redlands, California 92373
    United States

    Site Not Available

  • GSK Investigational Site

    San Diego, California 92123
    United States

    Site Not Available

  • GSK Investigational Site

    San Rafael, California 94901
    United States

    Site Not Available

  • GSK Investigational Site

    Santa Ana, California 92704
    United States

    Site Not Available

  • GSK Investigational Site

    Upland, California 91786
    United States

    Site Not Available

  • GSK Investigational Site

    Vista, California 92084
    United States

    Site Not Available

  • GSK Investigational Site

    Yuba City, California 95991
    United States

    Site Not Available

  • GSK Investigational Site

    Boulder, Colorado 80304
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80909
    United States

    Site Not Available

  • GSK Investigational Site

    Englewood, Colorado 80113
    United States

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  • GSK Investigational Site

    Wheat Ridge, Colorado 80033
    United States

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  • GSK Investigational Site

    Manchester, Connecticut 06040
    United States

    Site Not Available

  • GSK Investigational Site

    Boca Raton, Florida 33486
    United States

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  • GSK Investigational Site

    Boynton Beach, Florida 33437
    United States

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  • GSK Investigational Site

    Coral Gables, Florida 33134
    United States

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  • GSK Investigational Site

    Fort Myers, Florida 33916
    United States

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  • GSK Investigational Site

    Hialeah, Florida 33013
    United States

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  • GSK Investigational Site

    Hollywood, Florida 33021
    United States

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  • GSK Investigational Site

    Lake Worth, Florida 33461
    United States

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  • GSK Investigational Site

    Longwood, Florida 32779
    United States

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  • GSK Investigational Site

    Miami, Florida 33186
    United States

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  • GSK Investigational Site

    Naples, Florida 34102
    United States

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  • GSK Investigational Site

    New Port Richey, Florida 34652
    United States

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  • GSK Investigational Site

    Ocala, Florida 34471
    United States

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  • GSK Investigational Site

    Panama City, Florida 32405
    United States

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  • GSK Investigational Site

    Sarasota, Florida 34232
    United States

    Site Not Available

  • GSK Investigational Site

    St. Petersburg, Florida 33702
    United States

    Site Not Available

  • GSK Investigational Site

    Tallahassee, Florida 32308
    United States

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  • GSK Investigational Site

    Tampa, Florida 33614
    United States

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  • GSK Investigational Site

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • GSK Investigational Site

    Zephyrhills, Florida 33540
    United States

    Site Not Available

  • GSK Investigational Site

    Atlanta, Georgia 30342
    United States

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  • GSK Investigational Site

    Austell, Georgia 30106
    United States

    Site Not Available

  • GSK Investigational Site

    Decatur, Georgia 30033
    United States

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  • GSK Investigational Site

    Marietta, Georgia 30060
    United States

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  • GSK Investigational Site

    Martinez, Georgia 30907
    United States

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  • GSK Investigational Site

    Savannah, Georgia 31405
    United States

    Site Not Available

  • GSK Investigational Site

    Peoria, Illinois 61602
    United States

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  • GSK Investigational Site

    Riverside, Illinois 60546
    United States

    Site Not Available

  • GSK Investigational Site

    Indianapolis, Indiana 46250
    United States

    Site Not Available

  • GSK Investigational Site

    South Bend, Indiana 46601
    United States

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  • GSK Investigational Site

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • GSK Investigational Site

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • GSK Investigational Site

    Louisville, Kentucky 40202
    United States

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  • GSK Investigational Site

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • GSK Investigational Site

    Davenport, Louisiana 52807
    United States

    Site Not Available

  • GSK Investigational Site

    Baltimore, Maryland 21215
    United States

    Site Not Available

  • GSK Investigational Site

    Laurel, Maryland 20707
    United States

    Site Not Available

  • GSK Investigational Site

    Silver Spring, Maryland 20901
    United States

    Site Not Available

  • GSK Investigational Site

    Towson, Maryland 21204
    United States

    Site Not Available

  • GSK Investigational Site

    Attleboro, Massachusetts 2703
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • GSK Investigational Site

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • GSK Investigational Site

    Grand Rapids, Michigan 49546
    United States

    Site Not Available

  • GSK Investigational Site

    Oak Park, Michigan 48237
    United States

    Site Not Available

  • GSK Investigational Site

    St. Joseph, Michigan 49085
    United States

    Site Not Available

  • GSK Investigational Site

    Warren, Michigan 48089
    United States

    Site Not Available

  • GSK Investigational Site

    Chaska, Minnesota 55318
    United States

    Site Not Available

  • GSK Investigational Site

    St. Paul, Minnesota 55435
    United States

    Site Not Available

  • GSK Investigational Site

    Wentzville, Minnesota 62285
    United States

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  • GSK Investigational Site

    Jackson, Mississippi 39202
    United States

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  • GSK Investigational Site

    Jefferson City, Missouri 65109
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • GSK Investigational Site

    Missoula, Montana 59802
    United States

    Site Not Available

  • GSK Investigational Site

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • GSK Investigational Site

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • GSK Investigational Site

    Egg Harbor Township, New Jersey 08234
    United States

    Site Not Available

  • GSK Investigational Site

    Ocean, New Jersey 7712
    United States

    Site Not Available

  • GSK Investigational Site

    Vineland, New Jersey 8360
    United States

    Site Not Available

  • GSK Investigational Site

    West Caldwell, New Jersey 7006
    United States

    Site Not Available

  • GSK Investigational Site

    Farmington, New Mexico 87401
    United States

    Site Not Available

  • GSK Investigational Site

    Bayshore, New York 11706
    United States

    Site Not Available

  • GSK Investigational Site

    Great Neck, New York 11023
    United States

    Site Not Available

  • GSK Investigational Site

    Merrick, New York 11566
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, New York 14607
    United States

    Site Not Available

  • GSK Investigational Site

    Stony Brook, New York 11794-8091
    United States

    Site Not Available

  • GSK Investigational Site

    Syracuse, New York 13210
    United States

    Site Not Available

  • GSK Investigational Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • GSK Investigational Site

    Cary, North Carolina 27511
    United States

    Site Not Available

  • GSK Investigational Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28207
    United States

    Site Not Available

  • GSK Investigational Site

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • GSK Investigational Site

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • GSK Investigational Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • GSK Investigational Site

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Bismarck, North Dakota 58501
    United States

    Site Not Available

  • GSK Investigational Site

    Akron, Ohio 44302
    United States

    Site Not Available

  • GSK Investigational Site

    Beavercreek, Ohio 45431
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45224
    United States

    Site Not Available

  • GSK Investigational Site

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43212
    United States

    Site Not Available

  • GSK Investigational Site

    Dayton, Ohio 45440
    United States

    Site Not Available

  • GSK Investigational Site

    Kettering, Ohio 45429
    United States

    Site Not Available

  • GSK Investigational Site

    Lyndhurst, Ohio 44124
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • GSK Investigational Site

    Medford, Oregon 97504
    United States

    Site Not Available

  • GSK Investigational Site

    Altoona, Pennsylvania 16602
    United States

    Site Not Available

  • GSK Investigational Site

    Fleetwood, Pennsylvania 19522
    United States

    Site Not Available

  • GSK Investigational Site

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • GSK Investigational Site

    Newtown, Pennsylvania 18940
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • GSK Investigational Site

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • GSK Investigational Site

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • GSK Investigational Site

    Columbia, South Carolina 29240
    United States

    Site Not Available

  • GSK Investigational Site

    Simpsonville, South Carolina 29681
    United States

    Site Not Available

  • GSK Investigational Site

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • GSK Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • GSK Investigational Site

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Arlington, Texas 76012
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78745
    United States

    Site Not Available

  • GSK Investigational Site

    Corpus Christi, Texas 78412
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75204
    United States

    Site Not Available

  • GSK Investigational Site

    Houston, Texas 77024
    United States

    Site Not Available

  • GSK Investigational Site

    Humble, Texas 77338
    United States

    Site Not Available

  • GSK Investigational Site

    Irving, Texas 75061
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78205
    United States

    Site Not Available

  • GSK Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • GSK Investigational Site

    Tomball, Texas 77375
    United States

    Site Not Available

  • GSK Investigational Site

    Bountiful, Utah 84010
    United States

    Site Not Available

  • GSK Investigational Site

    Ogden, Utah 84405
    United States

    Site Not Available

  • GSK Investigational Site

    West Jordan, Utah 84088
    United States

    Site Not Available

  • GSK Investigational Site

    Alexandria, Virginia 22304
    United States

    Site Not Available

  • GSK Investigational Site

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • GSK Investigational Site

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • GSK Investigational Site

    Lacey, Washington 98516
    United States

    Site Not Available

  • GSK Investigational Site

    Spokane, Washington 99207
    United States

    Site Not Available

  • GSK Investigational Site

    Walla Walla, Washington 99362
    United States

    Site Not Available

  • GSK Investigational Site

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • GSK Investigational Site

    Yakima, Washington 98902
    United States

    Site Not Available

  • GSK Investigational Site

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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