Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
1 other identifier
interventional
702
2 countries
178
Brief 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.
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
178 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 21, 2003
CompletedFirst Posted
Study publicly available on registry
August 25, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedApril 16, 2015
April 1, 2015
1.6 years
August 21, 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.
Secondary Outcomes (1)
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
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 (178)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Calera, Alabama, 35040, United States
GSK Investigational Site
Tuscaloosa, Alabama, 35406, United States
GSK Investigational Site
Phoenix, Arizona, 85006, United States
GSK Investigational Site
Tucson, Arizona, 85723, United States
GSK Investigational Site
Fayetteville, Arkansas, 72701, United States
GSK Investigational Site
Chula Vista, California, 91910, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Garden Grove, California, 92840, United States
GSK Investigational Site
Lancaster, California, 93534, United States
GSK Investigational Site
Los Angeles, California, 90045, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Rancho Cucamonga, California, 91730, United States
GSK Investigational Site
Redlands, California, 92373, United States
GSK Investigational Site
San Diego, California, 92103, United States
GSK Investigational Site
San Diego, California, 92123, United States
GSK Investigational Site
San Rafael, California, 94901, United States
GSK Investigational Site
Santa Ana, California, 92704, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Vista, California, 92084, United States
GSK Investigational Site
Yuba City, California, 95991, United States
GSK Investigational Site
Boulder, Colorado, 80304, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Colorado Springs, Colorado, 80909, United States
GSK Investigational Site
Englewood, Colorado, 80113, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Manchester, Connecticut, 06040, United States
GSK Investigational Site
Boca Raton, Florida, 33486, United States
GSK Investigational Site
Boynton Beach, Florida, 33426, United States
GSK Investigational Site
Boynton Beach, Florida, 33437, United States
GSK Investigational Site
Coral Gables, Florida, 33134, United States
GSK Investigational Site
Fort Myers, Florida, 33907, United States
GSK Investigational Site
Fort Myers, Florida, 33916, United States
GSK Investigational Site
Hialeah, Florida, 33013, United States
GSK Investigational Site
Hollywood, Florida, 33021, United States
GSK Investigational Site
Lake Worth, Florida, 33461, United States
GSK Investigational Site
Longwood, Florida, 32779, United States
GSK Investigational Site
Miami, Florida, 33156, United States
GSK Investigational Site
Miami, Florida, 33186, United States
GSK Investigational Site
Naples, Florida, 34102, United States
GSK Investigational Site
New Port Richey, Florida, 34652, United States
GSK Investigational Site
Ocala, Florida, 34471, United States
GSK Investigational Site
Panama City, Florida, 32405, United States
GSK Investigational Site
Sarasota, Florida, 34232, United States
GSK Investigational Site
St. Petersburg, Florida, 33702, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Tampa, Florida, 33614, United States
GSK Investigational Site
West Palm Beach, Florida, 33407, United States
GSK Investigational Site
Zephyrhills, Florida, 33540, United States
GSK Investigational Site
Atlanta, Georgia, 30309, United States
GSK Investigational Site
Atlanta, Georgia, 30328, United States
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Martinez, Georgia, 30907, United States
GSK Investigational Site
Savannah, Georgia, 31405, United States
GSK Investigational Site
Peoria, Illinois, 61602, United States
GSK Investigational Site
Riverside, Illinois, 60546, United States
GSK Investigational Site
Indianapolis, Indiana, 46250, United States
GSK Investigational Site
Indianapolis, Indiana, 46254, United States
GSK Investigational Site
South Bend, Indiana, 46601, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Bowling Green, Kentucky, 42101, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Louisville, Kentucky, 40291, United States
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Davenport, Louisiana, 52807, United States
GSK Investigational Site
Baltimore, Maryland, 21215, United States
GSK Investigational Site
Laurel, Maryland, 20707, United States
GSK Investigational Site
Silver Spring, Maryland, 20901, United States
GSK Investigational Site
Silver Spring, Maryland, 20910, United States
GSK Investigational Site
Towson, Maryland, 21204, United States
GSK Investigational Site
Attleboro, Massachusetts, 2703, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Boston, Massachusetts, 02215, United States
GSK Investigational Site
Ann Arbor, Michigan, 48109, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
Grand Rapids, Michigan, 49546, United States
GSK Investigational Site
Oak Park, Michigan, 48237, United States
GSK Investigational Site
Saint Joseph, Michigan, 49085, United States
GSK Investigational Site
Warren, Michigan, 48089, United States
GSK Investigational Site
Chaska, Minnesota, 55318, United States
GSK Investigational Site
Saint Paul, Minnesota, 55435, United States
GSK Investigational Site
Wentzville, Minnesota, 62285, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Jefferson City, Missouri, 65101, United States
GSK Investigational Site
Jefferson City, Missouri, 65109, United States
GSK Investigational Site
Kansas City, Missouri, 64131, United States
GSK Investigational Site
Missoula, Montana, 59802, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Bloomfield, New Jersey, 07003, United States
GSK Investigational Site
Egg Harbor, New Jersey, 08234, United States
GSK Investigational Site
Ocean City, New Jersey, 7712, United States
GSK Investigational Site
Vineland, New Jersey, 8360, United States
GSK Investigational Site
West Caldwell, New Jersey, 7006, United States
GSK Investigational Site
Farmington, New Mexico, 87401, United States
GSK Investigational Site
Bay Shore, New York, 11706, United States
GSK Investigational Site
Great Neck, New York, 11023, United States
GSK Investigational Site
Merrick, New York, 11566, United States
GSK Investigational Site
Rochester, New York, 14607, United States
GSK Investigational Site
Stony Brook, New York, 11794-8091, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Cary, North Carolina, 27511, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Fayetteville, North Carolina, 28304, United States
GSK Investigational Site
Greenville, North Carolina, 27858, United States
GSK Investigational Site
Hickory, North Carolina, 28601, United States
GSK Investigational Site
High Point, North Carolina, 27262, United States
GSK Investigational Site
Morehead City, North Carolina, 28557, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Bismarck, North Dakota, 58501, United States
GSK Investigational Site
Akron, Ohio, 44302, United States
GSK Investigational Site
Beavercreek, Ohio, 45431, United States
GSK Investigational Site
Cincinnati, Ohio, 45219, United States
GSK Investigational Site
Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Cincinnati, Ohio, 45224, United States
GSK Investigational Site
Cleveland, Ohio, 44106, United States
GSK Investigational Site
Cleveland, Ohio, 44113, United States
GSK Investigational Site
Columbus, Ohio, 43212, United States
GSK Investigational Site
Dayton, Ohio, 45440, United States
GSK Investigational Site
Kettering, Ohio, 45429, United States
GSK Investigational Site
Lyndhurst, Ohio, 44124, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73112, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Altoona, Pennsylvania, 16602, United States
GSK Investigational Site
Fleetwood, Pennsylvania, 19522, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033, United States
GSK Investigational Site
Lancaster, Pennsylvania, 19096, United States
GSK Investigational Site
Newtown, Pennsylvania, 18940, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Columbia, South Carolina, 29240, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Simpsonville, South Carolina, 29681, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Memphis, Tennessee, 38120, United States
GSK Investigational Site
Murfreesboro, Tennessee, 37130, United States
GSK Investigational Site
Nashville, Tennessee, 37203, United States
GSK Investigational Site
Arlington, Texas, 76012, United States
GSK Investigational Site
Austin, Texas, 78745, United States
GSK Investigational Site
Corpus Christi, Texas, 78412, United States
GSK Investigational Site
Dallas, Texas, 75204, United States
GSK Investigational Site
Houston, Texas, 77024, United States
GSK Investigational Site
Houston, Texas, 77025, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Humble, Texas, 77338, United States
GSK Investigational Site
Irving, Texas, 75061, 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
Tomball, Texas, 77375, United States
GSK Investigational Site
Bountiful, Utah, 84010, United States
GSK Investigational Site
Ogden, Utah, 84405, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Alexandria, Virginia, 22304, United States
GSK Investigational Site
Charlottesville, Virginia, 22908, United States
GSK Investigational Site
Charlottesville, Virginia, 22911, United States
GSK Investigational Site
Chesapeake, Virginia, 23320, United States
GSK Investigational Site
Lacey, Washington, 98516, United States
GSK Investigational Site
Spokane, Washington, 99207, United States
GSK Investigational Site
Walla Walla, Washington, 99362, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Yakima, Washington, 98902, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53212, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53215, United States
GSK Investigational Site
Milwaukee, Wisconsin, 53226, 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 21, 2003
First Posted
August 25, 2003
Study Start
June 1, 2003
Primary Completion
January 1, 2005
Study Completion
January 1, 2005
Last Updated
April 16, 2015
Record last verified: 2015-04