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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067561
First received: August 21, 2003
Last updated: June 21, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Irritable Colon
Irritable Bowel Syndrome (IBS)
Drug: Alosetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.

Estimated Enrollment: 700
Study Start Date: June 2003
Intervention Details:
    Drug: Alosetron
    Other Name: Alosetron
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067561

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35235
GSK Investigational Site
Calera, Alabama, United States, 35040
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
United States, Arizona
GSK Investigational Site
Phoenix, Arizona, United States, 85006
GSK Investigational Site
Tucson, Arizona, United States, 85723
United States, Arkansas
GSK Investigational Site
Fayetteville, Arkansas, United States, 72701
United States, California
GSK Investigational Site
Chula Vista, California, United States, 91910
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
Garden Grove, California, United States, 92840
GSK Investigational Site
Lancaster, California, United States, 93534
GSK Investigational Site
Los Angeles, California, United States, 90045
GSK Investigational Site
Newport Beach, California, United States, 92663
GSK Investigational Site
Rancho Cucamonga, California, United States, 91730
GSK Investigational Site
Redlands, California, United States, 92373
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
San Diego, California, United States, 92123
GSK Investigational Site
San Rafael, California, United States, 94901
GSK Investigational Site
Santa Ana, California, United States, 92705
GSK Investigational Site
Santa Ana, California, United States, 92704
GSK Investigational Site
Upland, California, United States, 91786
GSK Investigational Site
Vista, California, United States, 92084
GSK Investigational Site
Yuba City, California, United States, 95991
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Englewood, Colorado, United States, 80113
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Manchester, Connecticut, United States, 06040
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33486
GSK Investigational Site
Boynton Beach, Florida, United States, 33426
GSK Investigational Site
Boynton Beach, Florida, United States, 33437
GSK Investigational Site
Coral Gables, Florida, United States, 33134
GSK Investigational Site
Fort Myers, Florida, United States, 33916
GSK Investigational Site
Fort Myers, Florida, United States, 33907
GSK Investigational Site
Hialeah, Florida, United States, 33013
GSK Investigational Site
Hollywood, Florida, United States, 33021
GSK Investigational Site
Lake Worth, Florida, United States, 33461
GSK Investigational Site
Longwood, Florida, United States, 32779
GSK Investigational Site
Miami, Florida, United States, 33156
GSK Investigational Site
Miami, Florida, United States, 33186
GSK Investigational Site
Naples, Florida, United States, 34102
GSK Investigational Site
New Port Richey, Florida, United States, 34652
GSK Investigational Site
Ocala, Florida, United States, 34471
GSK Investigational Site
Panama City, Florida, United States, 32405
GSK Investigational Site
Sarasota, Florida, United States, 34232
GSK Investigational Site
St. Petersburg, Florida, United States, 33702
GSK Investigational Site
Tallahassee, Florida, United States, 32308
GSK Investigational Site
Tampa, Florida, United States, 33614
GSK Investigational Site
West Palm Beach, Florida, United States, 33407
GSK Investigational Site
Zephyrhills, Florida, United States, 33540
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30328
GSK Investigational Site
Atlanta, Georgia, United States, 30309
GSK Investigational Site
Atlanta, Georgia, United States, 30342
GSK Investigational Site
Austell, Georgia, United States, 30106
GSK Investigational Site
Decatur, Georgia, United States, 30033
GSK Investigational Site
Marietta, Georgia, United States, 30060
GSK Investigational Site
Martinez, Georgia, United States, 30907
GSK Investigational Site
Savannah, Georgia, United States, 31405
United States, Illinois
GSK Investigational Site
Peoria, Illinois, United States, 61602
GSK Investigational Site
Riverside, Illinois, United States, 60546
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46254
GSK Investigational Site
Indianapolis, Indiana, United States, 46250
GSK Investigational Site
South Bend, Indiana, United States, 46601
United States, Kansas
GSK Investigational Site
Overland Park, Kansas, United States, 66211
United States, Kentucky
GSK Investigational Site
Bowling Green, Kentucky, United States, 42101
GSK Investigational Site
Louisville, Kentucky, United States, 40291
GSK Investigational Site
Louisville, Kentucky, United States, 40202
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
GSK Investigational Site
Davenport, Louisiana, United States, 52807
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21215
GSK Investigational Site
Laurel, Maryland, United States, 20707
GSK Investigational Site
Silver Spring, Maryland, United States, 20901
GSK Investigational Site
Silver Spring, Maryland, United States, 20910
GSK Investigational Site
Towson, Maryland, United States, 21204
United States, Massachusetts
GSK Investigational Site
Attleboro, Massachusetts, United States, 2703
GSK Investigational Site
Boston, Massachusetts, United States, 02215
GSK Investigational Site
Boston, Massachusetts, United States, 02114
United States, Michigan
GSK Investigational Site
Ann Arbor, Michigan, United States, 48109
GSK Investigational Site
Detroit, Michigan, United States, 48202
GSK Investigational Site
Grand Rapids, Michigan, United States, 49546
GSK Investigational Site
Oak Park, Michigan, United States, 48237
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
GSK Investigational Site
Warren, Michigan, United States, 48089
United States, Minnesota
GSK Investigational Site
Chaska, Minnesota, United States, 55318
GSK Investigational Site
St. Paul, Minnesota, United States, 55435
GSK Investigational Site
Wentzville, Minnesota, United States, 62285
United States, Mississippi
GSK Investigational Site
Jackson, Mississippi, United States, 39202
United States, Missouri
GSK Investigational Site
Jefferson City, Missouri, United States, 65101
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
GSK Investigational Site
Kansas City, Missouri, United States, 64131
United States, Montana
GSK Investigational Site
Missoula, Montana, United States, 59802
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
GSK Investigational Site
Bloomfield, New Jersey, United States, 07003
GSK Investigational Site
Egg Harbor Township, New Jersey, United States, 08234
GSK Investigational Site
Ocean, New Jersey, United States, 7712
GSK Investigational Site
Vineland, New Jersey, United States, 8360
GSK Investigational Site
West Caldwell, New Jersey, United States, 7006
United States, New Mexico
GSK Investigational Site
Farmington, New Mexico, United States, 87401
United States, New York
GSK Investigational Site
Bayshore, New York, United States, 11706
GSK Investigational Site
Great Neck, New York, United States, 11023
GSK Investigational Site
Merrick, New York, United States, 11566
GSK Investigational Site
Rochester, New York, United States, 14607
GSK Investigational Site
Stony Brook, New York, United States, 11794-8091
GSK Investigational Site
Syracuse, New York, United States, 13210
United States, North Carolina
GSK Investigational Site
Asheville, North Carolina, United States, 28801
GSK Investigational Site
Cary, North Carolina, United States, 27511
GSK Investigational Site
Chapel Hill, North Carolina, United States, 27599
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
GSK Investigational Site
Fayetteville, North Carolina, United States, 28304
GSK Investigational Site
Greenville, North Carolina, United States, 27858
GSK Investigational Site
Hickory, North Carolina, United States, 28601
GSK Investigational Site
High Point, North Carolina, United States, 27262
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
GSK Investigational Site
Bismarck, North Dakota, United States, 58501
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44302
GSK Investigational Site
Beavercreek, Ohio, United States, 45431
GSK Investigational Site
Cincinnati, Ohio, United States, 45224
GSK Investigational Site
Cincinnati, Ohio, United States, 45220
GSK Investigational Site
Cincinnati, Ohio, United States, 45219
GSK Investigational Site
Cleveland, Ohio, United States, 44113
GSK Investigational Site
Cleveland, Ohio, United States, 44106
GSK Investigational Site
Columbus, Ohio, United States, 43212
GSK Investigational Site
Dayton, Ohio, United States, 45440
GSK Investigational Site
Kettering, Ohio, United States, 45429
GSK Investigational Site
Lyndhurst, Ohio, United States, 44124
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
GSK Investigational Site
Tulsa, Oklahoma, United States, 74136
United States, Oregon
GSK Investigational Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
GSK Investigational Site
Altoona, Pennsylvania, United States, 16602
GSK Investigational Site
Fleetwood, Pennsylvania, United States, 19522
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
GSK Investigational Site
Lancaster, Pennsylvania, United States, 19096
GSK Investigational Site
Newtown, Pennsylvania, United States, 18940
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
GSK Investigational Site
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
GSK Investigational Site
East Providence, Rhode Island, United States, 02914
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29240
GSK Investigational Site
Greenville, South Carolina, United States, 29615
GSK Investigational Site
Simpsonville, South Carolina, United States, 29681
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
GSK Investigational Site
Memphis, Tennessee, United States, 38120
GSK Investigational Site
Memphis, Tennessee, United States, 38119
GSK Investigational Site
Murfreesboro, Tennessee, United States, 37130
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Arlington, Texas, United States, 76012
GSK Investigational Site
Austin, Texas, United States, 78745
GSK Investigational Site
Corpus Christi, Texas, United States, 78412
GSK Investigational Site
Dallas, Texas, United States, 75204
GSK Investigational Site
Houston, Texas, United States, 77030
GSK Investigational Site
Houston, Texas, United States, 77025
GSK Investigational Site
Houston, Texas, United States, 77024
GSK Investigational Site
Humble, Texas, United States, 77338
GSK Investigational Site
Irving, Texas, United States, 75061
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
San Antonio, Texas, United States, 78205
GSK Investigational Site
Sugar Land, Texas, United States, 77478
GSK Investigational Site
Tomball, Texas, United States, 77375
United States, Utah
GSK Investigational Site
Bountiful, Utah, United States, 84010
GSK Investigational Site
Ogden, Utah, United States, 84405
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Virginia
GSK Investigational Site
Alexandria, Virginia, United States, 22304
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
GSK Investigational Site
Charlottesville, Virginia, United States, 22908
GSK Investigational Site
Chesapeake, Virginia, United States, 23320
United States, Washington
GSK Investigational Site
Lacey, Washington, United States, 98516
GSK Investigational Site
Spokane, Washington, United States, 99207
GSK Investigational Site
Walla Walla, Washington, United States, 99362
GSK Investigational Site
Wenatchee, Washington, United States, 98801
GSK Investigational Site
Yakima, Washington, United States, 98902
United States, Wisconsin
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53215
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53209-0996
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53212
GSK Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 27408
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067561     History of Changes
Other Study ID Numbers: S3B30040
Study First Received: August 21, 2003
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Dose-ranging
Diarrhea-Predominant Irritable Bowel Syndrome
d-IBS
IBS
Irritable Bowel Syndrome

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Alosetron
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 13, 2014