Last updated: 11/04/2018 11:01:57
Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: Alosetron
Enrollment:
702
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Colon
Product
alosetron
Collaborators
Not applicable
Study date(s)
June 2003 to June 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18+ years
Accepts healthy volunteers
No
- Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
- Failed conventional therapy.
- History of or current chronic or severe constipation.
- Bloody diarrhea, abdominal pain with rectal bleeding.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Bismarck, North Dakota, United States, 58501
Status
Study Complete
Location
GSK Investigational Site
Farmington, New Mexico, United States, 87401
Status
Study Complete
Location
GSK Investigational Site
Bayshore, New York, United States, 11706
Status
Study Complete
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34652
Status
Study Complete
Location
GSK Investigational Site
Bowling Green, Kentucky, United States, 42101
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92123
Status
Recruiting
Location
GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Study Complete
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Will Be Recruiting
Location
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
Status
Recruiting
Location
GSK Investigational Site
Hialeah, Florida, United States, 33013
Status
Study Complete
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77478
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80113
Status
Study Complete
Location
GSK Investigational Site
Bloomfield, New Jersey, United States, 07003
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14607
Status
Will Be Recruiting
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Recruiting
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29240
Status
Recruiting
Location
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
Status
Study Complete
Location
GSK Investigational Site
Egg Harbor Township, New Jersey, United States, 08234
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Recruiting
Location
GSK Investigational Site
Newport Beach, California, United States, 92663
Status
Recruiting
Location
GSK Investigational Site
Chula Vista, California, United States, 91910
Status
Recruiting
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Study Complete
Location
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
Status
Study Complete
Location
GSK Investigational Site
Murfreesboro, Tennessee, United States, 37130
Status
Recruiting
Location
GSK Investigational Site
High Point, North Carolina, United States, 27262
Status
Recruiting
Location
GSK Investigational Site
Decatur, Georgia, United States, 30033
Status
Study Complete
Location
GSK Investigational Site
Rancho Cucamonga, California, United States, 91730
Status
Study Complete
Location
GSK Investigational Site
Lancaster, California, United States, 93534
Status
Recruiting
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Recruiting
Location
GSK Investigational Site
Beavercreek, Ohio, United States, 45431
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
Status
Recruiting
Location
GSK Investigational Site
Redlands, California, United States, 92373
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Recruiting
Location
GSK Investigational Site
Newtown, Pennsylvania, United States, 18940
Status
Recruiting
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Recruiting
Location
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
Status
Will Be Recruiting
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30328
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78412
Status
Recruiting
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65101
Status
Study Complete
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46254
Status
Study Complete
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Recruiting
Location
GSK Investigational Site
Greenville, South Carolina, United States, 29615
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Recruiting
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Will Be Recruiting
Location
GSK Investigational Site
Garden Grove, California, United States, 92840
Status
Recruiting
Location
GSK Investigational Site
Grand Rapids, Michigan, United States, 49546
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
Status
Study Complete
Location
GSK Investigational Site
Wentzville, Minnesota, United States, 62285
Status
Recruiting
Location
GSK Investigational Site
Manchester, Connecticut, United States, 06040
Status
Recruiting
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Recruiting
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20901
Status
Study Complete
Location
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
Status
Recruiting
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Recruiting
Location
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
Status
Recruiting
Location
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
Status
Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Recruiting
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Recruiting
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22304
Status
Recruiting
Location
GSK Investigational Site
Stony Brook, New York, United States, 11794-8091
Status
Recruiting
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Recruiting
Location
GSK Investigational Site
Zephyrhills, Florida, United States, 33540
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92704
Status
Recruiting
Location
GSK Investigational Site
San Rafael, California, United States, 94901
Status
Study Complete
Location
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
Status
Recruiting
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Will Be Recruiting
Location
GSK Investigational Site
Kansas City, Missouri, United States, 64131
Status
Study Complete
Location
GSK Investigational Site
Hickory, North Carolina, United States, 28601
Status
Recruiting
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21215
Status
Study Complete
Location
GSK Investigational Site
Santa Ana, California, United States, 92705
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90045
Status
Recruiting
Location
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
Status
Recruiting
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
Status
Recruiting
Location
GSK Investigational Site
Cary, North Carolina, United States, 27511
Status
Recruiting
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Recruiting
Location
GSK Investigational Site
Great Neck, New York, United States, 11023
Status
Recruiting
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
Status
Study Complete
Location
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
Status
Recruiting
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Recruiting
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53212
Status
Recruiting
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
Status
Recruiting
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 27408
Status
Recruiting
Location
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
Status
Recruiting
Location
GSK Investigational Site
Coral Gables, Florida, United States, 33134
Status
Recruiting
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Status
Study Complete
Location
GSK Investigational Site
Davenport, Louisiana, United States, 52807
Status
Recruiting
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
Status
Study Complete
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 19096
Status
Will Be Recruiting
Location
GSK Investigational Site
Panama City, Florida, United States, 32405
Status
Recruiting
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
Status
Recruiting
Location
GSK Investigational Site
Merrick, New York, United States, 11566
Status
Study Complete
Location
GSK Investigational Site
Upland, California, United States, 91786
Status
Study Complete
Location
GSK Investigational Site
Warren, Michigan, United States, 48089
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72701
Status
Study Complete
Location
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33426
Status
Recruiting
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02215
Status
Recruiting
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Status
Recruiting
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
Status
Study Complete
Location
GSK Investigational Site
West Caldwell, New Jersey, United States, 7006
Status
Recruiting
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27858
Status
Recruiting
Location
GSK Investigational Site
Attleboro, Massachusetts, United States, 2703
Status
Recruiting
Location
GSK Investigational Site
Detroit, Michigan, United States, 48202
Status
Study Complete
Location
GSK Investigational Site
Yuba City, California, United States, 95991
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
Status
Recruiting
Location
GSK Investigational Site
Sarasota, Florida, United States, 34232
Status
Study Complete
Location
GSK Investigational Site
Missoula, Montana, United States, 59802
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
Status
Recruiting
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Recruiting
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Recruiting
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Will Be Recruiting
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-01-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
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