Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
A 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects With Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy
1 other identifier
interventional
700
2 countries
191
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2003
191 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 20, 2003
CompletedFirst Posted
Study publicly available on registry
August 21, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 16, 2015
April 1, 2015
2.5 years
August 20, 2003
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.
12 Weeks
Secondary Outcomes (1)
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.
12 Weeks
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
- Failed conventional therapy.
- Willing to make daily calls on a touch-tone telephone.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (191)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Birmingham, Alabama, 35242, United States
GSK Investigational Site
Huntsville, Alabama, 35801, United States
GSK Investigational Site
Mobile, Alabama, 36693, United States
GSK Investigational Site
Pell City, Alabama, 35125, United States
GSK Investigational Site
Tallassee, Alabama, 36078, United States
GSK Investigational Site
Tucson, Arizona, 85712, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
North Little Rock, Arkansas, 72117, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Carlsbad, California, 92008, United States
GSK Investigational Site
Concord, California, 94520, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Garden Grove, California, 92840, United States
GSK Investigational Site
Los Angeles, California, 90035, United States
GSK Investigational Site
Orange, California, 92868, United States
GSK Investigational Site
Roseville, California, 95661, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
San Diego, California, 92120, United States
GSK Investigational Site
San Francisco, California, 94114, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
San Francisco, California, 94122, United States
GSK Investigational Site
Santa Ana, California, 92704, United States
GSK Investigational Site
Spring Valley, California, 91978, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Van Nuys, California, 91405, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Littleton, Colorado, 80120, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Bristol, Connecticut, 06010, United States
GSK Investigational Site
Belleair Bluffs, Florida, 33770, United States
GSK Investigational Site
Boca Raton, Florida, 33428, United States
GSK Investigational Site
Bradenton, Florida, 34209, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Clearwater, Florida, 33765, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Gainesville, Florida, 32607, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Jacksonville, Florida, 32256-6004, United States
GSK Investigational Site
Kissimmee, Florida, 34741, United States
GSK Investigational Site
Melbourne, Florida, 32901, United States
GSK Investigational Site
North Miami Beach, Florida, 33162, United States
GSK Investigational Site
Spring Hill, Florida, 34608, United States
GSK Investigational Site
Stuart, Florida, 34996, United States
GSK Investigational Site
Zephyrhills, Florida, 33540, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30339, United States
GSK Investigational Site
Blue Ridge, Georgia, 30513, United States
GSK Investigational Site
Dunwoody, Georgia, 30328, United States
GSK Investigational Site
Fayetteville, Georgia, 30214, United States
GSK Investigational Site
Rome, Georgia, 30165, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Boise, Idaho, 83702, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Meridian, Idaho, 83642, United States
GSK Investigational Site
Chicago, Illinois, 60612-7323, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Libertyville, Illinois, 60048, United States
GSK Investigational Site
Moline, Illinois, 61265, United States
GSK Investigational Site
Morton Grove, Illinois, 61550, United States
GSK Investigational Site
Oakbrook Terrace, Illinois, 60181, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Rockford, Illinois, 61107, United States
GSK Investigational Site
Indianapolis, Indiana, 46208, United States
GSK Investigational Site
Indianapolis, Indiana, 46237, United States
GSK Investigational Site
Jeffersonville, Indiana, 47130, United States
GSK Investigational Site
Clive, Iowa, 50325, United States
GSK Investigational Site
Haysville, Kansas, 67060, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
GSK Investigational Site
Wichita, Kansas, 67203, United States
GSK Investigational Site
Florence, Kentucky, 41042, United States
GSK Investigational Site
Lexington, Kentucky, 40508, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Covington, Louisiana, 70433, United States
GSK Investigational Site
Lafayette, Louisiana, 70508, United States
GSK Investigational Site
Monroe, Louisiana, 71201, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
New Orleans, Louisiana, 70128, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Baltimore, Maryland, 21215, United States
GSK Investigational Site
Baltimore, Maryland, 21229, United States
GSK Investigational Site
Lanham, Maryland, 20706, United States
GSK Investigational Site
Oxon Hill, Maryland, 20745, United States
GSK Investigational Site
Severna Park, Maryland, 21146, United States
GSK Investigational Site
Silver Spring, Maryland, 20910, United States
GSK Investigational Site
Towson, Maryland, 21204-7736, United States
GSK Investigational Site
Towson, Maryland, 21204, United States
GSK Investigational Site
Wheaton, Maryland, 20906, United States
GSK Investigational Site
Burlington, Massachusetts, 01805, United States
GSK Investigational Site
Farmington Hills, Michigan, 48334, United States
GSK Investigational Site
Northville, Michigan, 48167, United States
GSK Investigational Site
Petoskey, Michigan, 49770, United States
GSK Investigational Site
Saginaw, Michigan, 48602, United States
GSK Investigational Site
Brooklyn Center, Minnesota, 55430, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Lincoln, Nebraska, 68503, United States
GSK Investigational Site
Omaha, Nebraska, 68144, United States
GSK Investigational Site
Las Vegas, Nevada, 89119, United States
GSK Investigational Site
Berlin, New Jersey, 08009, United States
GSK Investigational Site
Blackwood, New Jersey, 08012, United States
GSK Investigational Site
Cedar Knolls, New Jersey, 7927, United States
GSK Investigational Site
Oakhurst, New Jersey, 07755, United States
GSK Investigational Site
Passaic, New Jersey, 07055, United States
GSK Investigational Site
South Bound Brook, New Jersey, 08880, United States
GSK Investigational Site
Willingboro, New Jersey, 08046, United States
GSK Investigational Site
Albuquerque, New Mexico, 87106, United States
GSK Investigational Site
Albany, New York, 12205, United States
GSK Investigational Site
Binghamton, New York, 13901, United States
GSK Investigational Site
Endwell, New York, 13760, United States
GSK Investigational Site
Great Neck, New York, 11023, United States
GSK Investigational Site
Pittsford, New York, 14534, United States
GSK Investigational Site
Pomona, New York, 10970, United States
GSK Investigational Site
Cary, North Carolina, 27511, United States
GSK Investigational Site
Charlotte, North Carolina, 28262, United States
GSK Investigational Site
Gastonia, North Carolina, 28054, United States
GSK Investigational Site
Greensboro, North Carolina, 27403, United States
GSK Investigational Site
Greenville, North Carolina, 27858, United States
GSK Investigational Site
Jacksonville, North Carolina, 28546, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Wilmington, North Carolina, 28412, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Bellbrook, Ohio, 45305, United States
GSK Investigational Site
Cincinnati, Ohio, 45236, United States
GSK Investigational Site
Columbus, Ohio, 43207, United States
GSK Investigational Site
Columbus, Ohio, 43215, United States
GSK Investigational Site
Wandsworth, Ohio, 44281, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Tulsa, Oklahoma, 74135, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Portland, Oregon, 97225, United States
GSK Investigational Site
Bensalem, Pennsylvania, 19020, United States
GSK Investigational Site
Duncansville, Pennsylvania, 16635, United States
GSK Investigational Site
Feasterville, Pennsylvania, 19053, United States
GSK Investigational Site
Levittown, Pennsylvania, 19057, United States
GSK Investigational Site
Media, Pennsylvania, 19063, United States
GSK Investigational Site
Morrisville, Pennsylvania, 19067, United States
GSK Investigational Site
Penndel, Pennsylvania, 19047, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19106, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19148, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15218, United States
GSK Investigational Site
Reading, Pennsylvania, 19611, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Stoneboro, Pennsylvania, 16153, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29407, United States
GSK Investigational Site
Summerville, South Carolina, 29485, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57105, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Clarksville, Tennessee, 37043, United States
GSK Investigational Site
Jackson, Tennessee, 38305, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Knoxville, Tennessee, 37920, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Nashville, Tennessee, 37205, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
Conroe, Texas, 77304, United States
GSK Investigational Site
Dallas, Texas, 75230, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Humble, Texas, 77338, United States
GSK Investigational Site
North Richland Hills, Texas, 76180, United States
GSK Investigational Site
Pasadena, Texas, 77505, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Sugar Land, Texas, 77478, United States
GSK Investigational Site
The Woodlands, Texas, 77381, United States
GSK Investigational Site
Salt Lake City, Utah, 84132, United States
GSK Investigational Site
Chesapeake, Virginia, 23320, United States
GSK Investigational Site
Christiansburg, Virginia, 24073, United States
GSK Investigational Site
Danville, Virginia, 24541, United States
GSK Investigational Site
Norfolk, Virginia, 23502, United States
GSK Investigational Site
Norfolk, Virginia, 23507, United States
GSK Investigational Site
Richmond, Virginia, 23294, United States
GSK Investigational Site
Virginia Beach, Virginia, 23455, United States
GSK Investigational Site
Weber City, Virginia, 24290, United States
GSK Investigational Site
Bellevue, Washington, 98004, United States
GSK Investigational Site
Gig Harbor, Washington, 98335, United States
GSK Investigational Site
Lacey, Washington, 98516, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Nedlands, Western Australia, 27408, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2003
First Posted
August 21, 2003
Study Start
June 1, 2003
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
April 16, 2015
Record last verified: 2015-04