Study In 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

Colic

Gastroparesis

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT00067457
S3B30048
  • Ages > 18
  • Female

Study Summary

The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for 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: 700
Study Start date:
June 01, 2003
Estimated Completion Date:
December 31, 2005

Connect with a study center

  • GSK Investigational Site

    Nedlands, Western Australia 27408
    Australia

    Site Not Available

  • GSK Investigational Site

    Birmingham, Alabama 35242
    United States

    Site Not Available

  • GSK Investigational Site

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • GSK Investigational Site

    Mobile, Alabama 36693
    United States

    Site Not Available

  • GSK Investigational Site

    Pell City, Alabama 35125
    United States

    Site Not Available

  • GSK Investigational Site

    Tallassee, Alabama 36078
    United States

    Site Not Available

  • GSK Investigational Site

    Tucson, Arizona 85712
    United States

    Site Not Available

  • GSK Investigational Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • GSK Investigational Site

    North Little Rock, Arkansas 72117
    United States

    Site Not Available

  • GSK Investigational Site

    Beverly Hills, California 90211
    United States

    Site Not Available

  • GSK Investigational Site

    Carlsbad, California 92008
    United States

    Site Not Available

  • GSK Investigational Site

    Concord, California 94520
    United States

    Site Not Available

  • GSK Investigational Site

    Encinitas, California 92024
    United States

    Site Not Available

  • GSK Investigational Site

    Fresno, California 93720
    United States

    Site Not Available

  • GSK Investigational Site

    Garden Grove, California 92840
    United States

    Site Not Available

  • GSK Investigational Site

    Los Angeles, California 90035
    United States

    Site Not Available

  • GSK Investigational Site

    Orange, California 92868
    United States

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  • GSK Investigational Site

    Roseville, California 95661
    United States

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  • GSK Investigational Site

    San Diego, California 92120
    United States

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  • GSK Investigational Site

    San Francisco, California 94114
    United States

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  • GSK Investigational Site

    Santa Ana, California 92704
    United States

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  • GSK Investigational Site

    Spring Valley, California 91978
    United States

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  • GSK Investigational Site

    Torrance, California 90505
    United States

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  • GSK Investigational Site

    Van Nuys, California 91405
    United States

    Site Not Available

  • GSK Investigational Site

    Centennial, Colorado 80112
    United States

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  • GSK Investigational Site

    Colorado Springs, Colorado 80909
    United States

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  • GSK Investigational Site

    Littleton, Colorado 80120
    United States

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    Longmont, Colorado 80501
    United States

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  • GSK Investigational Site

    Bristol, Connecticut 06010
    United States

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    Belleair Bluffs, Florida 33770
    United States

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    Boca Raton, Florida 33428
    United States

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    Bradenton, Florida 34209
    United States

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  • GSK Investigational Site

    Clearwater, Florida 33765
    United States

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  • GSK Investigational Site

    Deland, Florida 32720
    United States

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  • GSK Investigational Site

    Gainesville, Florida 32607
    United States

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  • GSK Investigational Site

    Hollywood, Florida 33021
    United States

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  • GSK Investigational Site

    Jacksonville, Florida 32256-6004
    United States

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  • GSK Investigational Site

    Kissimmee, Florida 34741
    United States

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  • GSK Investigational Site

    Melbourne, Florida 32901
    United States

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    North Miami Beach, Florida 33162
    United States

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    Spring Hill, Florida 34608
    United States

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    Stuart, Florida 34996
    United States

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  • GSK Investigational Site

    Zephyrhills, Florida 33540
    United States

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  • GSK Investigational Site

    Atlanta, Georgia 30339
    United States

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    Blue Ridge, Georgia 30513
    United States

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  • GSK Investigational Site

    Dunwoody, Georgia 30328
    United States

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  • GSK Investigational Site

    Fayetteville, Georgia 30214
    United States

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    Rome, Georgia 30165
    United States

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    Savannah, Georgia 31405
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    Boise, Idaho 83702
    United States

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  • GSK Investigational Site

    Coeur D'Alene, Idaho 83814
    United States

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  • GSK Investigational Site

    Meridian, Idaho 83642
    United States

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  • GSK Investigational Site

    Chicago, Illinois 60637
    United States

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  • GSK Investigational Site

    Libertyville, Illinois 60048
    United States

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  • GSK Investigational Site

    Moline, Illinois 61265
    United States

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  • GSK Investigational Site

    Morton Grove, Illinois 61550
    United States

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  • GSK Investigational Site

    Oakbrook Terrace, Illinois 60181
    United States

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  • GSK Investigational Site

    Peoria, Illinois 61602
    United States

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  • GSK Investigational Site

    Rockford, Illinois 61107
    United States

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  • GSK Investigational Site

    Indianapolis, Indiana 46237
    United States

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  • GSK Investigational Site

    Jeffersonville, Indiana 47130
    United States

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  • GSK Investigational Site

    Clive, Iowa 50325
    United States

    Site Not Available

  • GSK Investigational Site

    Haysville, Kansas 67060
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67203
    United States

    Site Not Available

  • GSK Investigational Site

    Florence, Kentucky 41042
    United States

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  • GSK Investigational Site

    Lexington, Kentucky 40508
    United States

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  • GSK Investigational Site

    Madisonville, Kentucky 42431
    United States

    Site Not Available

  • GSK Investigational Site

    Covington, Louisiana 70433
    United States

    Site Not Available

  • GSK Investigational Site

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • GSK Investigational Site

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • GSK Investigational Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • GSK Investigational Site

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • GSK Investigational Site

    Annapolis, Maryland 21401
    United States

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  • GSK Investigational Site

    Baltimore, Maryland 21229
    United States

    Site Not Available

  • GSK Investigational Site

    Lanham, Maryland 20706
    United States

    Site Not Available

  • GSK Investigational Site

    Oxon Hill, Maryland 20745
    United States

    Site Not Available

  • GSK Investigational Site

    Severna Park, Maryland 21146
    United States

    Site Not Available

  • GSK Investigational Site

    Silver Spring, Maryland 20910
    United States

    Site Not Available

  • GSK Investigational Site

    Towson, Maryland 21204
    United States

    Site Not Available

  • GSK Investigational Site

    Wheaton, Maryland 20906
    United States

    Site Not Available

  • GSK Investigational Site

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • GSK Investigational Site

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • GSK Investigational Site

    Northville, Michigan 48167
    United States

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  • GSK Investigational Site

    Petoskey, Michigan 49770
    United States

    Site Not Available

  • GSK Investigational Site

    Saginaw, Michigan 48602
    United States

    Site Not Available

  • GSK Investigational Site

    Brooklyn Center, Minnesota 55430
    United States

    Site Not Available

  • GSK Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • GSK Investigational Site

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • GSK Investigational Site

    Lincoln, Nebraska 68503
    United States

    Site Not Available

  • GSK Investigational Site

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • GSK Investigational Site

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • GSK Investigational Site

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • GSK Investigational Site

    Blackwood, New Jersey 08012
    United States

    Site Not Available

  • GSK Investigational Site

    Cedar Knolls, New Jersey 7927
    United States

    Site Not Available

  • GSK Investigational Site

    Oakhurst, New Jersey 07755
    United States

    Site Not Available

  • GSK Investigational Site

    Passaic, New Jersey 07055
    United States

    Site Not Available

  • GSK Investigational Site

    South Bound Brook, New Jersey 08880
    United States

    Site Not Available

  • GSK Investigational Site

    Willingboro, New Jersey 08046
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87106
    United States

    Site Not Available

  • GSK Investigational Site

    Albany, New York 12205
    United States

    Site Not Available

  • GSK Investigational Site

    Binghamton, New York 13901
    United States

    Site Not Available

  • GSK Investigational Site

    Endwell, New York 13760
    United States

    Site Not Available

  • GSK Investigational Site

    Great Neck, New York 11023
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsford, New York 14534
    United States

    Site Not Available

  • GSK Investigational Site

    Pomona, New York 10970
    United States

    Site Not Available

  • GSK Investigational Site

    Cary, North Carolina 27511
    United States

    Site Not Available

  • GSK Investigational Site

    Charlotte, North Carolina 28262
    United States

    Site Not Available

  • GSK Investigational Site

    Gastonia, North Carolina 28054
    United States

    Site Not Available

  • GSK Investigational Site

    Greensboro, North Carolina 27403
    United States

    Site Not Available

  • GSK Investigational Site

    Greenville, North Carolina 27858
    United States

    Site Not Available

  • GSK Investigational Site

    Raleigh, North Carolina 27609
    United States

    Site Not Available

  • GSK Investigational Site

    Wilmington, North Carolina 28412
    United States

    Site Not Available

  • GSK Investigational Site

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • GSK Investigational Site

    Bellbrook, Ohio 45305
    United States

    Site Not Available

  • GSK Investigational Site

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • GSK Investigational Site

    Columbus, Ohio 43207
    United States

    Site Not Available

  • GSK Investigational Site

    Wandsworth, Ohio 44281
    United States

    Site Not Available

  • GSK Investigational Site

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • GSK Investigational Site

    Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • GSK Investigational Site

    Portland, Oregon 97225
    United States

    Site Not Available

  • GSK Investigational Site

    Bensalem, Pennsylvania 19020
    United States

    Site Not Available

  • GSK Investigational Site

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • GSK Investigational Site

    Feasterville, Pennsylvania 19053
    United States

    Site Not Available

  • GSK Investigational Site

    Levittown, Pennsylvania 19057
    United States

    Site Not Available

  • GSK Investigational Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • GSK Investigational Site

    Morrisville, Pennsylvania 19067
    United States

    Site Not Available

  • GSK Investigational Site

    Penndel, Pennsylvania 19047
    United States

    Site Not Available

  • GSK Investigational Site

    Philadelphia, Pennsylvania 19148
    United States

    Site Not Available

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15218
    United States

    Site Not Available

  • GSK Investigational Site

    Reading, Pennsylvania 19611
    United States

    Site Not Available

  • GSK Investigational Site

    Sellersville, Pennsylvania 18960
    United States

    Site Not Available

  • GSK Investigational Site

    Stoneboro, Pennsylvania 16153
    United States

    Site Not Available

  • GSK Investigational Site

    Anderson, South Carolina 29621
    United States

    Site Not Available

  • GSK Investigational Site

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • GSK Investigational Site

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • GSK Investigational Site

    Sioux Falls, South Dakota 57105
    United States

    Site Not Available

  • GSK Investigational Site

    Clarksville, Tennessee 37043
    United States

    Site Not Available

  • GSK Investigational Site

    Jackson, Tennessee 38305
    United States

    Site Not Available

  • GSK Investigational Site

    Johnson City, Tennessee 37601
    United States

    Site Not Available

  • GSK Investigational Site

    Kingsport, Tennessee 37660
    United States

    Site Not Available

  • GSK Investigational Site

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • GSK Investigational Site

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • GSK Investigational Site

    Austin, Texas 78758
    United States

    Site Not Available

  • GSK Investigational Site

    Conroe, Texas 77304
    United States

    Site Not Available

  • GSK Investigational Site

    Dallas, Texas 75230
    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

    North Richland Hills, Texas 76180
    United States

    Site Not Available

  • GSK Investigational Site

    Pasadena, Texas 77505
    United States

    Site Not Available

  • GSK Investigational Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • GSK Investigational Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • GSK Investigational Site

    Woodlands, Texas 77381
    United States

    Site Not Available

  • GSK Investigational Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • GSK Investigational Site

    Chesapeake, Virginia 23320
    United States

    Site Not Available

  • GSK Investigational Site

    Christiansburg, Virginia 24073
    United States

    Site Not Available

  • GSK Investigational Site

    Danville, Virginia 24541
    United States

    Site Not Available

  • GSK Investigational Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond, Virginia 23294
    United States

    Site Not Available

  • GSK Investigational Site

    Virginia Beach, Virginia 23455
    United States

    Site Not Available

  • GSK Investigational Site

    Weber City, Virginia 24290
    United States

    Site Not Available

  • GSK Investigational Site

    Bellevue, Washington 98004
    United States

    Site Not Available

  • GSK Investigational Site

    Gig Harbor, Washington 98335
    United States

    Site Not Available

  • GSK Investigational Site

    Lacey, Washington 98516
    United States

    Site Not Available

  • GSK Investigational Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • GSK Investigational Site

    La Crosse, Wisconsin 54601
    United States

    Site Not Available

  • GSK Investigational Site

    Madison, Wisconsin 53792
    United States

    Site Not Available

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