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

April 15, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

702

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 27408
        • GSK Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • GSK Investigational Site
      • Calera, Alabama, United States, 35040
        • GSK Investigational Site
      • Tuscaloosa, Alabama, United States, 35406
        • GSK Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • GSK Investigational Site
      • Tucson, Arizona, United States, 85723
        • GSK Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • GSK Investigational Site
    • California
      • 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, 92704
        • GSK Investigational Site
      • Santa Ana, California, United States, 92705
        • 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
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80907
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • GSK Investigational Site
      • Englewood, Colorado, United States, 80113
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • GSK Investigational Site
    • Florida
      • Boca Raton, Florida, United States, 33486
        • GSK Investigational Site
      • Boynton Beach, Florida, United States, 33437
        • GSK Investigational Site
      • Boynton Beach, Florida, United States, 33426
        • 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
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30328
        • 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
        • GSK Investigational Site
    • Illinois
      • Peoria, Illinois, United States, 61602
        • GSK Investigational Site
      • Riverside, Illinois, United States, 60546
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46254
        • GSK Investigational Site
      • South Bend, Indiana, United States, 46601
        • GSK Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • GSK Investigational Site
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40291
        • GSK Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • GSK Investigational Site
    • Louisiana
      • Davenport, Louisiana, United States, 52807
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • GSK Investigational Site
      • Laurel, Maryland, United States, 20707
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20910
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20901
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204
        • GSK Investigational Site
    • Massachusetts
      • Attleboro, Massachusetts, United States, 2703
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02114
        • GSK Investigational Site
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
    • Michigan
      • 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
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
      • St. Paul, Minnesota, United States, 55435
        • GSK Investigational Site
      • Wentzville, Minnesota, United States, 62285
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • GSK Investigational Site
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • GSK Investigational Site
      • Jefferson City, Missouri, United States, 65101
        • GSK Investigational Site
      • Kansas City, Missouri, United States, 64131
        • GSK Investigational Site
    • Montana
      • Missoula, Montana, United States, 59802
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • New Jersey
      • 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
        • GSK Investigational Site
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • GSK Investigational Site
    • New York
      • 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
        • GSK Investigational Site
    • North Carolina
      • 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
        • GSK Investigational Site
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44302
        • GSK Investigational Site
      • Beavercreek, Ohio, United States, 45431
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45224
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45220
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44113
        • 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
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74136
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
    • Pennsylvania
      • 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
        • GSK Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29240
        • GSK Investigational Site
      • Greenville, South Carolina, United States, 29615
        • GSK Investigational Site
      • Simpsonville, South Carolina, United States, 29681
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
      • Murfreesboro, Tennessee, United States, 37130
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • 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, 77024
        • GSK Investigational Site
      • Houston, Texas, United States, 77025
        • 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
        • GSK Investigational Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • GSK Investigational Site
      • Ogden, Utah, United States, 84405
        • GSK Investigational Site
      • West Jordan, Utah, United States, 84088
        • GSK Investigational Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • GSK Investigational Site
      • Charlottesville, Virginia, United States, 22908
        • GSK Investigational Site
      • Charlottesville, Virginia, United States, 22911
        • GSK Investigational Site
      • Chesapeake, Virginia, United States, 23320
        • GSK Investigational Site
    • Washington
      • 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
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

August 21, 2003

First Submitted That Met QC Criteria

August 22, 2003

First Posted (Estimate)

August 25, 2003

Study Record Updates

Last Update Posted (Estimate)

April 16, 2015

Last Update Submitted That Met QC Criteria

April 15, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S3B30040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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