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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2003

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2003

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2003

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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