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

April 15, 2015 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

700

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
      • Birmingham, Alabama, United States, 35242
        • GSK Investigational Site
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
      • Mobile, Alabama, United States, 36693
        • GSK Investigational Site
      • Pell City, Alabama, United States, 35125
        • GSK Investigational Site
      • Tallassee, Alabama, United States, 36078
        • GSK Investigational Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • GSK Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • GSK Investigational Site
      • North Little Rock, Arkansas, United States, 72117
        • GSK Investigational Site
    • California
      • Beverly Hills, California, United States, 90211
        • GSK Investigational Site
      • Carlsbad, California, United States, 92008
        • GSK Investigational Site
      • Concord, California, United States, 94520
        • GSK Investigational Site
      • Encinitas, California, United States, 92024
        • GSK Investigational Site
      • Fresno, California, United States, 93720
        • GSK Investigational Site
      • Garden Grove, California, United States, 92840
        • GSK Investigational Site
      • Los Angeles, California, United States, 90035
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Roseville, California, United States, 95661
        • GSK Investigational Site
      • San Diego, California, United States, 92103
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
      • San Francisco, California, United States, 94115
        • GSK Investigational Site
      • San Francisco, California, United States, 94114
        • GSK Investigational Site
      • San Francisco, California, United States, 94122
        • GSK Investigational Site
      • Santa Ana, California, United States, 92704
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Torrance, California, United States, 90505
        • GSK Investigational Site
      • Van Nuys, California, United States, 91405
        • GSK Investigational Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • GSK Investigational Site
      • Colorado Springs, Colorado, United States, 80909
        • GSK Investigational Site
      • Littleton, Colorado, United States, 80120
        • GSK Investigational Site
      • Longmont, Colorado, United States, 80501
        • GSK Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • GSK Investigational Site
    • Florida
      • Belleair Bluffs, Florida, United States, 33770
        • GSK Investigational Site
      • Boca Raton, Florida, United States, 33428
        • GSK Investigational Site
      • Bradenton, Florida, United States, 34209
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33756
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33765
        • GSK Investigational Site
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Gainesville, Florida, United States, 32607
        • GSK Investigational Site
      • Hollywood, Florida, United States, 33021
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32256-6004
        • GSK Investigational Site
      • Jacksonville, Florida, United States, 32209
        • GSK Investigational Site
      • Kissimmee, Florida, United States, 34741
        • GSK Investigational Site
      • Melbourne, Florida, United States, 32901
        • GSK Investigational Site
      • North Miami Beach, Florida, United States, 33162
        • GSK Investigational Site
      • Spring Hill, Florida, United States, 34608
        • GSK Investigational Site
      • Stuart, Florida, United States, 34996
        • GSK Investigational Site
      • Zephyrhills, Florida, United States, 33540
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • GSK Investigational Site
      • Atlanta, Georgia, United States, 30328
        • GSK Investigational Site
      • Blue Ridge, Georgia, United States, 30513
        • GSK Investigational Site
      • Dunwoody, Georgia, United States, 30328
        • GSK Investigational Site
      • Fayetteville, Georgia, United States, 30214
        • GSK Investigational Site
      • Rome, Georgia, United States, 30165
        • GSK Investigational Site
      • Savannah, Georgia, United States, 31405
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • GSK Investigational Site
      • Coeur D'Alene, Idaho, United States, 83814
        • GSK Investigational Site
      • Meridian, Idaho, United States, 83642
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • GSK Investigational Site
      • Chicago, Illinois, United States, 60612-7323
        • GSK Investigational Site
      • Libertyville, Illinois, United States, 60048
        • GSK Investigational Site
      • Moline, Illinois, United States, 61265
        • GSK Investigational Site
      • Morton Grove, Illinois, United States, 61550
        • GSK Investigational Site
      • Oakbrook Terrace, Illinois, United States, 60181
        • GSK Investigational Site
      • Peoria, Illinois, United States, 61602
        • GSK Investigational Site
      • Rockford, Illinois, United States, 61107
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46208
        • GSK Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • GSK Investigational Site
    • Iowa
      • Clive, Iowa, United States, 50325
        • GSK Investigational Site
    • Kansas
      • Haysville, Kansas, United States, 67060
        • GSK Investigational Site
      • Kansas City, Kansas, United States, 66160
        • GSK Investigational Site
      • Wichita, Kansas, United States, 67203
        • GSK Investigational Site
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40536
        • GSK Investigational Site
      • Lexington, Kentucky, United States, 40508
        • GSK Investigational Site
      • Madisonville, Kentucky, United States, 42431
        • GSK Investigational Site
    • Louisiana
      • Covington, Louisiana, United States, 70433
        • GSK Investigational Site
      • Lafayette, Louisiana, United States, 70508
        • GSK Investigational Site
      • Monroe, Louisiana, United States, 71201
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70112
        • GSK Investigational Site
      • New Orleans, Louisiana, United States, 70128
        • GSK Investigational Site
      • Shreveport, Louisiana, United States, 71103
        • GSK Investigational Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21229
        • GSK Investigational Site
      • Baltimore, Maryland, United States, 21215
        • GSK Investigational Site
      • Lanham, Maryland, United States, 20706
        • GSK Investigational Site
      • Oxon Hill, Maryland, United States, 20745
        • GSK Investigational Site
      • Severna Park, Maryland, United States, 21146
        • GSK Investigational Site
      • Silver Spring, Maryland, United States, 20910
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204
        • GSK Investigational Site
      • Towson, Maryland, United States, 21204-7736
        • GSK Investigational Site
      • Wheaton, Maryland, United States, 20906
        • GSK Investigational Site
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • GSK Investigational Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • GSK Investigational Site
      • Northville, Michigan, United States, 48167
        • GSK Investigational Site
      • Petoskey, Michigan, United States, 49770
        • GSK Investigational Site
      • Saginaw, Michigan, United States, 48602
        • GSK Investigational Site
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • GSK Investigational Site
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • GSK Investigational Site
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68144
        • GSK Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • GSK Investigational Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • GSK Investigational Site
      • Blackwood, New Jersey, United States, 08012
        • GSK Investigational Site
      • Cedar Knolls, New Jersey, United States, 7927
        • GSK Investigational Site
      • Oakhurst, New Jersey, United States, 07755
        • GSK Investigational Site
      • Passaic, New Jersey, United States, 07055
        • GSK Investigational Site
      • South Bound Brook, New Jersey, United States, 08880
        • GSK Investigational Site
      • Willingboro, New Jersey, United States, 08046
        • GSK Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • GSK Investigational Site
      • Binghamton, New York, United States, 13901
        • GSK Investigational Site
      • Endwell, New York, United States, 13760
        • GSK Investigational Site
      • Great Neck, New York, United States, 11023
        • GSK Investigational Site
      • Pittsford, New York, United States, 14534
        • GSK Investigational Site
      • Pomona, New York, United States, 10970
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28262
        • GSK Investigational Site
      • Gastonia, North Carolina, United States, 28054
        • GSK Investigational Site
      • Greensboro, North Carolina, United States, 27403
        • GSK Investigational Site
      • Greenville, North Carolina, United States, 27858
        • GSK Investigational Site
      • Jacksonville, North Carolina, United States, 28546
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Bellbrook, Ohio, United States, 45305
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
      • Columbus, Ohio, United States, 43207
        • GSK Investigational Site
      • Wandsworth, Ohio, United States, 44281
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74135
        • GSK Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97225
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • Pennsylvania
      • Bensalem, Pennsylvania, United States, 19020
        • GSK Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • GSK Investigational Site
      • Feasterville, Pennsylvania, United States, 19053
        • GSK Investigational Site
      • Levittown, Pennsylvania, United States, 19057
        • GSK Investigational Site
      • Media, Pennsylvania, United States, 19063
        • GSK Investigational Site
      • Morrisville, Pennsylvania, United States, 19067
        • GSK Investigational Site
      • Penndel, Pennsylvania, United States, 19047
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19106
        • GSK Investigational Site
      • Philadelphia, Pennsylvania, United States, 19148
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15218
        • GSK Investigational Site
      • Reading, Pennsylvania, United States, 19611
        • GSK Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • GSK Investigational Site
      • Stoneboro, Pennsylvania, United States, 16153
        • GSK Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • GSK Investigational Site
      • Charleston, South Carolina, United States, 29407
        • GSK Investigational Site
      • Summerville, South Carolina, United States, 29485
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Clarksville, Tennessee, United States, 37043
        • GSK Investigational Site
      • Jackson, Tennessee, United States, 38305
        • GSK Investigational Site
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
      • Kingsport, Tennessee, United States, 37660
        • GSK Investigational Site
      • Knoxville, Tennessee, United States, 37920
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
      • Nashville, Tennessee, United States, 37205
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78758
        • GSK Investigational Site
      • Conroe, Texas, United States, 77304
        • GSK Investigational Site
      • Dallas, Texas, United States, 75230
        • GSK Investigational Site
      • Houston, Texas, United States, 77024
        • GSK Investigational Site
      • Humble, Texas, United States, 77338
        • GSK Investigational Site
      • North Richland Hills, Texas, United States, 76180
        • GSK Investigational Site
      • Pasadena, Texas, United States, 77505
        • 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
      • Woodlands, Texas, United States, 77381
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • GSK Investigational Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • GSK Investigational Site
      • Christiansburg, Virginia, United States, 24073
        • GSK Investigational Site
      • Danville, Virginia, United States, 24541
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23502
        • GSK Investigational Site
      • Norfolk, Virginia, United States, 23507
        • GSK Investigational Site
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
      • Virginia Beach, Virginia, United States, 23455
        • GSK Investigational Site
      • Weber City, Virginia, United States, 24290
        • GSK Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • GSK Investigational Site
      • Gig Harbor, Washington, United States, 98335
        • GSK Investigational Site
      • Lacey, Washington, United States, 98516
        • GSK Investigational Site
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • GSK Investigational Site
      • Madison, Wisconsin, United States, 53792
        • 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
Time Frame
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.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 Weeks
12 Weeks

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)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

August 20, 2003

First Submitted That Met QC Criteria

August 20, 2003

First Posted (Estimate)

August 21, 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

  • S3B30048

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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