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


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Irritable Bowel Syndrome

Irritable Bowel Syndrome (IBS); Spastic Colon 




Clinical Trial: Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

This study is currently recruiting patients.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline

Purpose

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.

Condition Treatment or Intervention Phase
Irritable Bowel Syndrome
 Drug: Investigational IBS Drug
Phase III

MedlinePlus related topics:  Irritable Bowel Syndrome

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

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 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

Location and Contact Information


Alabama
      Pell City,  Alabama,  35128,  United States; No longer recruiting

      Birmingham,  Alabama,  35242,  United States; No longer recruiting

      Huntsville,  Alabama,  35801,  United States; Recruiting
Study Coordinator  256-536-6600 

      Tallassee,  Alabama,  36078,  United States; Recruiting
Study Coordinator  334-283-8224 

      Mobile,  Alabama,  36693,  United States; Recruiting
Study Coordinator  251-660-5504 

Arizona
      Tucson,  Arizona,  85712,  United States; Recruiting
Study Coordinator  520-323-9601 

      Tucson,  Arizona,  85712,  United States; Recruiting
Study Coordinator  520-881-3595 

      Oro Valley,  Arizona,  85739,  United States; No longer recruiting

Arkansas
      North Little Rock,  Arkansas,  72117,  United States; Recruiting
Study Coordinator  501-945-3343 

      Little Rock,  Arkansas,  72205,  United States; No longer recruiting

      Little Rock,  Arkansas,  72205,  United States; No longer recruiting

California
      Los Angeles,  California,  90035,  United States; Recruiting
Study Coordinator  310-553-8555 

      Beverly Hills,  California,  90211,  United States; Recruiting
Study Coordinator  310-652-8084 

      Torrance,  California,  90505,  United States; Recruiting
Study Coordinator  310-373-9397 

      Van Nuys,  California,  91405,  United States; No longer recruiting

      Carlsbad,  California,  92008,  United States; No longer recruiting

      Encinitas,  California,  92024,  United States; No longer recruiting

      San Diego,  California,  92103,  United States; No longer recruiting

      San Diego,  California,  92108,  United States; Recruiting
Study Coordinator  619-521-2830 

      San Diego,  California,  92108,  United States; Recruiting
Study Coordinator  619-293-0644 

      San Diego,  California,  92120,  United States; No longer recruiting

      San Diego,  California,  92120,  United States; Recruiting
Study Coordinator  619-583-1954 

      San Diego,  California,  92120,  United States; Recruiting
Study Coordinator  619-582-5564 

      Orange,  California,  92868,  United States; Recruiting
Study Coordinator  714-628-8877 

      Fresno,  California,  93720,  United States; Recruiting
Study Coordinator  559-431-9571 

      San Francisco,  California,  94114,  United States; No longer recruiting

      San Francisco,  California,  94115,  United States; Recruiting
Study Coordinator  415-600-1155 

      San Francisco,  California,  94117,  United States; Recruiting
Study Coordinator  415-681-4657 

      Concord,  California,  94520,  United States; No longer recruiting

      Roseville,  California,  95661,  United States; Recruiting
Study Coordinator  916-773-6200 

Colorado
      Centennial,  Colorado,  80112,  United States; Recruiting
Study Coordinator  303-773-9000 

      Littleton,  Colorado,  80120,  United States; Recruiting
Study Coordinator  303-279-1550 

      Longmont,  Colorado,  80501,  United States; No longer recruiting

      Colorado Springs,  Colorado,  80909,  United States; Recruiting
Study Coordinator  719-636-3784 

Connecticut
      Bristol,  Connecticut,  06010,  United States; Recruiting
Study Coordinator  860-585-3838 

District of Columbia
      Washington,  District of Columbia,  20010,  United States; Terminated

Florida
      Jacksonville,  Florida,  32204,  United States; No longer recruiting

      Jacksonville,  Florida,  32209,  United States; No longer recruiting

      Jacksonville,  Florida,  32256,  United States; Recruiting
Study Coordinator  904-680-0871 

      Gainesville,  Florida,  32605,  United States; Recruiting
Study Coordinator  352-333-3885 

      Deland,  Florida,  32720,  United States; Recruiting
Study Coordinator  904-740-0770 

      Melbourne,  Florida,  32901,  United States; Recruiting
Study Coordinator  321-722-9305 

      Hollywood,  Florida,  33021,  United States; No longer recruiting

      Miami,  Florida,  33156,  United States; Recruiting
Study Coordinator  305-670-3901 

      North Miami Beach,  Florida,  33162,  United States; No longer recruiting

      Boca Raton,  Florida,  33428,  United States; Recruiting
Study Coordinator  561-852-0885 

      Zephyrhills,  Florida,  33540,  United States; Recruiting
Study Coordinator  813-780-8368 

      Clearwater,  Florida,  33756,  United States; No longer recruiting

      Clearwater,  Florida,  33765,  United States; Recruiting
Study Coordinator  727-466-0078 

      Belleair Bluffs,  Florida,  33770,  United States; Recruiting
Study Coordinator  727-587-9009 

      Bradenton,  Florida,  34209,  United States; No longer recruiting

      Bradenton,  Florida,  34209,  United States; No longer recruiting

      Spring Hill,  Florida,  34608,  United States; Recruiting
Study Coordinator  352-666-9894 

      Kissimmee,  Florida,  34741,  United States; No longer recruiting

      Stuart,  Florida,  34996,  United States; Recruiting
Study Coordinator  772-781-3000 

Georgia
      Marietta,  Georgia,  30067,  United States; No longer recruiting

      Rome,  Georgia,  30165,  United States; Recruiting
Study Coordinator  706-238-8036 

      Fayetteville,  Georgia,  30214,  United States; No longer recruiting

      Atlanta,  Georgia,  30328,  United States; Recruiting
Study Coordinator  404-459-6699 

      Dunwoody,  Georgia,  30338,  United States; Recruiting
Study Coordinator  770-936-0083 

      Atlanta,  Georgia,  30339,  United States; Recruiting
Study Coordinator  770-333-8380 

      Blue Ridge,  Georgia,  30513,  United States; No longer recruiting

      Savannah,  Georgia,  31404,  United States; No longer recruiting

Idaho
      Meridian,  Idaho,  83642,  United States; No longer recruiting

      Boise,  Idaho,  83705,  United States; Recruiting
Study Coordinator  208-947-0970 

      Coeur D Alene,  Idaho,  83814,  United States; No longer recruiting

Illinois
      Glenview,  Illinois,  60025,  United States; Recruiting
Study Coordinator  847-570-2460 

      Libertyville,  Illinois,  60048,  United States; No longer recruiting

      Oakbrook Terrace,  Illinois,  60181,  United States; No longer recruiting

      Evanston,  Illinois,  60201,  United States; No longer recruiting

      Chicago,  Illinois,  60612,  United States; Recruiting
Study Coordinator  312-355-4071 

      Chicago,  Illinois,  60637,  United States; No longer recruiting

      Rockford,  Illinois,  61107,  United States; Recruiting
Study Coordinator  815-484-7804 

      Moline,  Illinois,  61265,  United States; Recruiting
Study Coordinator  309-762-5560 

      Morton,  Illinois,  61550,  United States; Recruiting
Study Coordinator  309-263-2411 

      Peoria,  Illinois,  61602,  United States; Recruiting
Study Coordinator  309-672-1910  Ext. 122 

Indiana
      Indianapolis,  Indiana,  46208,  United States; No longer recruiting

      Indianapolis,  Indiana,  46237,  United States; Recruiting
Study Coordinator  317-865-2959 

      Jeffersonville,  Indiana,  47130,  United States; No longer recruiting

      Evansville,  Indiana,  47714,  United States; No longer recruiting

Iowa
      Clive,  Iowa,  50325,  United States; Recruiting
Study Coordinator  515-225-6050 

Kansas
      Kansas City,  Kansas,  66160,  United States; Recruiting
Study Coordinator  913-588-3852 

      Haysville,  Kansas,  67060,  United States; No longer recruiting

      Wichita,  Kansas,  67203,  United States; No longer recruiting

Kentucky
      Lexington,  Kentucky,  40504,  United States; Recruiting
Study Coordinator  859-977-4005 

      Lexington,  Kentucky,  40536,  United States; Recruiting
Study Coordinator  859-323-6423 

      Florence,  Kentucky,  41042,  United States; Recruiting
Study Coordinator  800-792-7393 

Louisiana
      New Orleans,  Louisiana,  70112,  United States; Recruiting
Study Coordinator  504-524-2061 

      New Orleans,  Louisiana,  70128,  United States; No longer recruiting

      Covington,  Louisiana,  70433,  United States; Recruiting
Study Coordinator  985-893-9230 

      Lafayette,  Louisiana,  70506,  United States; Recruiting
Study Coordinator  337-268-9339 

      Shreveport,  Louisiana,  71103,  United States; Recruiting
Study Coordinator  318-631-9121 

      Bastrop,  Louisiana,  71220,  United States; Recruiting
Study Coordinator  318-381-2360 

Maryland
      Lanham,  Maryland,  20706,  United States; No longer recruiting

      Oxon Hill,  Maryland,  20745,  United States; Recruiting
Study Coordinator  301-839-2916 

      Wheaton,  Maryland,  20906,  United States; No longer recruiting

      Severna Park,  Maryland,  21146,  United States; Recruiting
Study Coordinator  410-353-0597 

      Towson,  Maryland,  21204,  United States; No longer recruiting

      Towson,  Maryland,  21204,  United States; Recruiting
Study Coordinator  410-769-9300 

      Baltimore,  Maryland,  21215,  United States; No longer recruiting

      Baltimore,  Maryland,  21229,  United States; Recruiting
Study Coordinator  410-737-0053 

      Annapolis,  Maryland,  21401,  United States; Recruiting
Study Coordinator  410-224-4887 

Massachusetts
      Burlington,  Massachusetts,  01805,  United States; No longer recruiting

Michigan
      Northville,  Michigan,  48167,  United States; No longer recruiting

      Farmington Hills,  Michigan,  48334,  United States; No longer recruiting

      Saginaw,  Michigan,  48602,  United States; Recruiting
Study Coordinator  989-583-6891 

      Petoskey,  Michigan,  49770,  United States; Recruiting
Study Coordinator  231-487-3207 

Minnesota
      Arden Hills,  Minnesota,  55126,  United States; No longer recruiting

      Brooklyn Center,  Minnesota,  55430,  United States; Recruiting
Study Coordinator  763-746-9010 

Missouri
      Chesterfield,  Missouri,  63017,  United States; Recruiting
Study Coordinator  314-205-0007 

      Chesterfield,  Missouri,  63017,  United States; Recruiting
Study Coordinator  314-878-1905 

Nebraska
      Omaha,  Nebraska,  68144,  United States; Recruiting
Study Coordinator  402-330-7781 

      Lincoln,  Nebraska,  68503,  United States; No longer recruiting

Nevada
      Henderson,  Nevada,  89014,  United States; Recruiting
Study Coordinator  702-990-4338 

      Las Vegas,  Nevada,  89119,  United States; Recruiting
Study Coordinator  888-424-2001  Ext. 206 

New Jersey
      Passaic,  New Jersey,  07055,  United States; No longer recruiting

      Oakhurst,  New Jersey,  07755,  United States; Recruiting
Study Coordinator  732-517-0060 

      Cedar Knolls,  New Jersey,  07927,  United States; Recruiting
Study Coordinator  973-401-0500 

      Berlin,  New Jersey,  08009,  United States; Recruiting
Study Coordinator  856-753-7335 

      Blackwood,  New Jersey,  08012,  United States; Recruiting
Study Coordinator  856-228-0144 

      Willingboro,  New Jersey,  08046,  United States; No longer recruiting

      Hillsborough,  New Jersey,  08844,  United States; No longer recruiting

      South Bound Brook,  New Jersey,  08880,  United States; No longer recruiting

New Mexico
      Albuquerque,  New Mexico,  87106,  United States; No longer recruiting

New York
      Pomona,  New York,  10970,  United States; No longer recruiting

      Albany,  New York,  12205,  United States; No longer recruiting

      Endwell,  New York,  13760,  United States; Recruiting
Study Coordinator  607-754-6247 

      Binghamton,  New York,  13903,  United States; Recruiting
Study Coordinator  607-772-1029 

      Pittsford,  New York,  14534,  United States; Recruiting
Study Coordinator  585-899-4039 

North Carolina
      Greensboro,  North Carolina,  27403,  United States; Recruiting
Study Coordinator  336-547-1890 

      Cary,  North Carolina,  27560,  United States; No longer recruiting

      Raleigh,  North Carolina,  27609,  United States; No longer recruiting

      Greenville,  North Carolina,  27858,  United States; Recruiting
Study Coordinator  252-744-2330 

      Gastonia,  North Carolina,  28054,  United States; Recruiting
Study Coordinator  704-866-9200 

      Charlotte,  North Carolina,  28262,  United States; Recruiting
Study Coordinator  704-503-3216 

      Wilmington,  North Carolina,  28401,  United States; Recruiting
Study Coordinator  910-763-1219 

      Wilmington,  North Carolina,  28412,  United States; Recruiting
Study Coordinator  910-799-5500 

      Jacksonville,  North Carolina,  28546,  United States; No longer recruiting

Ohio
      Columbus,  Ohio,  43207,  United States; Recruiting
Study Coordinator  614-444-1040 

      Columbus,  Ohio,  43215,  United States; No longer recruiting

      Wadsworth,  Ohio,  44281,  United States; No longer recruiting

      Cincinnati,  Ohio,  45236,  United States; No longer recruiting

      Bellbrook,  Ohio,  45305,  United States; Recruiting
Study Coordinator  937-848-3900 

Oklahoma
      Tulsa,  Oklahoma,  74135,  United States; Recruiting
Study Coordinator  918-749-3399 

Oregon
      Portland,  Oregon,  97210,  United States; No longer recruiting

      Portland,  Oregon,  97225,  United States; Recruiting
Study Coordinator  503-282-6452 

      Eugene,  Oregon,  97401,  United States; Recruiting
Study Coordinator  514-747-3172 

Pennsylvania
      Pittsburgh,  Pennsylvania,  15218,  United States; No longer recruiting

      Stoneboro,  Pennsylvania,  16153,  United States; No longer recruiting

      Duncansville,  Pennsylvania,  16635,  United States; Recruiting
Study Coordinator  814-693-0300 

      Perkasie,  Pennsylvania,  18944,  United States; Recruiting
Study Coordinator  215-257-5128 

      Sellersville,  Pennsylvania,  18960,  United States; No longer recruiting

      Bensalem,  Pennsylvania,  19020,  United States; Recruiting
Study Coordinator  215-752-1810 

      Penndel,  Pennsylvania,  19047,  United States; No longer recruiting

      Feasterville Trevose,  Pennsylvania,  19053,  United States; Recruiting
Study Coordinator  215-355-9770 

      Levittown,  Pennsylvania,  19057,  United States; No longer recruiting

      Media,  Pennsylvania,  19063,  United States; No longer recruiting

      Morrisville,  Pennsylvania,  19067,  United States; Recruiting
Study Coordinator  215-736-8520 

      Philadelphia,  Pennsylvania,  19106,  United States; No longer recruiting

      Philadelphia,  Pennsylvania,  19107,  United States; Recruiting
Study Coordinator  215-762-5417 

      Philadelphia,  Pennsylvania,  19148,  United States; Recruiting
Study Coordinator  215-389-6461 

      Temple,  Pennsylvania,  19560,  United States; Recruiting
Study Coordinator  610-929-9484 

South Carolina
      Charleston,  South Carolina,  29407,  United States; Recruiting
Study Coordinator  843-766-5045 

      Summerville,  South Carolina,  29485,  United States; Recruiting
Study Coordinator  843-851-7098 

      Anderson,  South Carolina,  29621,  United States; Recruiting
Study Coordinator  864-225-7401 

South Dakota
      Sioux Falls,  South Dakota,  57105,  United States; Recruiting
Study Coordinator  605-322-8630 

Tennessee
      Clarksville,  Tennessee,  37043,  United States; No longer recruiting

      Nashville,  Tennessee,  37205,  United States; Recruiting
Study Coordinator  615-292-3012 

      Johnson City,  Tennessee,  37601,  United States; Recruiting
Study Coordinator  423-854-8952 

      Bristol,  Tennessee,  37620,  United States; No longer recruiting

      Kingsport,  Tennessee,  37660,  United States; Recruiting
Study Coordinator  423-230-3154 

      Knoxville,  Tennessee,  37920,  United States; No longer recruiting

      Jackson,  Tennessee,  38305,  United States; Recruiting
Study Coordinator  731-661-9559 

Texas
      Dallas,  Texas,  75230,  United States; Recruiting
Study Coordinator  214-346-9909 

      North Richland Hills,  Texas,  76180,  United States; Recruiting
Study Coordinator  817-595-3399 

      Houston,  Texas,  77024,  United States; Terminated

      Houston,  Texas,  77024,  United States; Recruiting
Study Coordinator  713-973-6993 

      Conroe,  Texas,  77304,  United States; No longer recruiting

      Conroe,  Texas,  77304,  United States; Recruiting
Study Coordinator  281-364-2063 

      Humble,  Texas,  77338,  United States; Recruiting
Study Coordinator  281-364-2063 

      The Woodlands,  Texas,  77381,  United States; No longer recruiting

      Sugar Land,  Texas,  77478,  United States; No longer recruiting

      Pasadena,  Texas,  77505,  United States; No longer recruiting

      San Antonio,  Texas,  78205,  United States; No longer recruiting

      San Antonio,  Texas,  78229,  United States; No longer recruiting

      Austin,  Texas,  78758,  United States; Recruiting
Study Coordinator  512-349-0139 

Utah
      Salt Lake City,  Utah,  84132,  United States; Recruiting
Study Coordinator  801-581-3693 

Virginia
      Richmond,  Virginia,  23294,  United States; Recruiting
Study Coordinator  804-672-2133 

      Virginia Beach,  Virginia,  23455,  United States; Recruiting
Study Coordinator  757-460-4300 

      Norfolk,  Virginia,  23502,  United States; No longer recruiting

      Norfolk,  Virginia,  23502,  United States; Recruiting
Study Coordinator  757-466-0165 

      Norfolk,  Virginia,  23502,  United States; Recruiting
Study Coordinator  757-461-3633 

      Norfolk,  Virginia,  23507,  United States; No longer recruiting

      Christiansburg,  Virginia,  24073,  United States; Recruiting
Study Coordinator  540-382-9405 

      Weber City,  Virginia,  24290,  United States; No longer recruiting

      Danville,  Virginia,  24541,  United States; Recruiting
Study Coordinator  434-792-2339 

Washington
      Bellevue,  Washington,  98004,  United States; No longer recruiting

      Gig Harbor,  Washington,  98335,  United States; No longer recruiting

      Tacoma,  Washington,  98405,  United States; Recruiting
Study Coordinator  253-272-8664 

Wisconsin
      Madison,  Wisconsin,  53792,  United States; Recruiting
Study Coordinator  608-266-6088 

      La Crosse,  Wisconsin,  54601,  United States; Recruiting
Study Coordinator  608-785-5132 

More Information

Study ID Numbers:  S3B30048
Record last reviewed:  January 2005
Last Updated:  January 4, 2005
Record first received:  August 20, 2003
ClinicalTrials.gov Identifier:  NCT00067457
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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December 2, 2009



Page Updated: October 15, 2009
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