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ClinicalTrials.gov record
Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00067457

Public ClinicalTrials.gov record NCT00067457. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 8:05 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00067457
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
GlaxoSmithKline
Industry
Enrollment
700 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2003 (Type not available)
Primary completion
Dec 2005 (Actual)
Completion
Dec 2005 (Actual)
Last update posted
Apr 16, 2015

2003 – 2005

United States locations

U.S. sites
190
U.S. states
38
U.S. cities
169
Facility City State ZIP Site status
GSK Investigational Site Birmingham Alabama 35235 —
GSK Investigational Site Birmingham Alabama 35242 —
GSK Investigational Site Huntsville Alabama 35801 —
GSK Investigational Site Mobile Alabama 36693 —
GSK Investigational Site Pell City Alabama 35125 —
GSK Investigational Site Tallassee Alabama 36078 —
GSK Investigational Site Tucson Arizona 85712 —
GSK Investigational Site Little Rock Arkansas 72205 —
GSK Investigational Site North Little Rock Arkansas 72117 —
GSK Investigational Site Beverly Hills California 90211 —
GSK Investigational Site Carlsbad California 92008 —
GSK Investigational Site Concord California 94520 —
GSK Investigational Site Encinitas California 92024 —
GSK Investigational Site Fresno California 93720 —
GSK Investigational Site Garden Grove California 92840 —
GSK Investigational Site Los Angeles California 90035 —
GSK Investigational Site Orange California 92868 —
GSK Investigational Site Roseville California 95661 —
GSK Investigational Site San Diego California 92103 —
GSK Investigational Site San Diego California 92108 —
GSK Investigational Site San Diego California 92120 —
GSK Investigational Site San Francisco California 94114 —
GSK Investigational Site San Francisco California 94115 —
GSK Investigational Site San Francisco California 94122 —
GSK Investigational Site Santa Ana California 92704 —
GSK Investigational Site Spring Valley California 91978 —
GSK Investigational Site Torrance California 90505 —
GSK Investigational Site Van Nuys California 91405 —
GSK Investigational Site Centennial Colorado 80112 —
GSK Investigational Site Colorado Springs Colorado 80909 —
GSK Investigational Site Littleton Colorado 80120 —
GSK Investigational Site Longmont Colorado 80501 —
GSK Investigational Site Bristol Connecticut 06010 —
GSK Investigational Site Belleair Bluffs Florida 33770 —
GSK Investigational Site Boca Raton Florida 33428 —
GSK Investigational Site Bradenton Florida 34209 —
GSK Investigational Site Clearwater Florida 33756 —
GSK Investigational Site Clearwater Florida 33765 —
GSK Investigational Site DeLand Florida 32720 —
GSK Investigational Site Gainesville Florida 32607 —
GSK Investigational Site Hollywood Florida 33021 —
GSK Investigational Site Jacksonville Florida 32209 —
GSK Investigational Site Jacksonville Florida 32256-6004 —
GSK Investigational Site Kissimmee Florida 34741 —
GSK Investigational Site Melbourne Florida 32901 —
GSK Investigational Site North Miami Beach Florida 33162 —
GSK Investigational Site Spring Hill Florida 34608 —
GSK Investigational Site Stuart Florida 34996 —
GSK Investigational Site Zephyrhills Florida 33540 —
GSK Investigational Site Atlanta Georgia 30328 —
GSK Investigational Site Atlanta Georgia 30339 —
GSK Investigational Site Blue Ridge Georgia 30513 —
GSK Investigational Site Dunwoody Georgia 30328 —
GSK Investigational Site Fayetteville Georgia 30214 —
GSK Investigational Site Rome Georgia 30165 —
GSK Investigational Site Savannah Georgia 31405 —
GSK Investigational Site Boise Idaho 83702 —
GSK Investigational Site Coeur d'Alene Idaho 83814 —
GSK Investigational Site Meridian Idaho 83642 —
GSK Investigational Site Chicago Illinois 60612-7323 —
GSK Investigational Site Chicago Illinois 60637 —
GSK Investigational Site Libertyville Illinois 60048 —
GSK Investigational Site Moline Illinois 61265 —
GSK Investigational Site Morton Grove Illinois 61550 —
GSK Investigational Site Oakbrook Terrace Illinois 60181 —
GSK Investigational Site Peoria Illinois 61602 —
GSK Investigational Site Rockford Illinois 61107 —
GSK Investigational Site Indianapolis Indiana 46208 —
GSK Investigational Site Indianapolis Indiana 46237 —
GSK Investigational Site Jeffersonville Indiana 47130 —
GSK Investigational Site Clive Iowa 50325 —
GSK Investigational Site Haysville Kansas 67060 —
GSK Investigational Site Kansas City Kansas 66160 —
GSK Investigational Site Wichita Kansas 67203 —
GSK Investigational Site Florence Kentucky 41042 —
GSK Investigational Site Lexington Kentucky 40508 —
GSK Investigational Site Lexington Kentucky 40536 —
GSK Investigational Site Madisonville Kentucky 42431 —
GSK Investigational Site Covington Louisiana 70433 —
GSK Investigational Site Lafayette Louisiana 70508 —
GSK Investigational Site Monroe Louisiana 71201 —
GSK Investigational Site New Orleans Louisiana 70112 —
GSK Investigational Site New Orleans Louisiana 70128 —
GSK Investigational Site Shreveport Louisiana 71103 —
GSK Investigational Site Annapolis Maryland 21401 —
GSK Investigational Site Baltimore Maryland 21215 —
GSK Investigational Site Baltimore Maryland 21229 —
GSK Investigational Site Lanham Maryland 20706 —
GSK Investigational Site Oxon Hill Maryland 20745 —
GSK Investigational Site Severna Park Maryland 21146 —
GSK Investigational Site Silver Spring Maryland 20910 —
GSK Investigational Site Towson Maryland 21204-7736 —
GSK Investigational Site Towson Maryland 21204 —
GSK Investigational Site Wheaton Maryland 20906 —
GSK Investigational Site Burlington Massachusetts 01805 —
GSK Investigational Site Farmington Hills Michigan 48334 —
GSK Investigational Site Northville Michigan 48167 —
GSK Investigational Site Petoskey Michigan 49770 —
GSK Investigational Site Saginaw Michigan 48602 —
GSK Investigational Site Brooklyn Center Minnesota 55430 —
GSK Investigational Site Chesterfield Missouri 63017 —
GSK Investigational Site St Louis Missouri 63141 —
GSK Investigational Site Lincoln Nebraska 68503 —
GSK Investigational Site Omaha Nebraska 68144 —
GSK Investigational Site Las Vegas Nevada 89119 —
GSK Investigational Site Berlin New Jersey 08009 —
GSK Investigational Site Blackwood New Jersey 08012 —
GSK Investigational Site Cedar Knolls New Jersey 7927 —
GSK Investigational Site Oakhurst New Jersey 07755 —
GSK Investigational Site Passaic New Jersey 07055 —
GSK Investigational Site South Bound Brook New Jersey 08880 —
GSK Investigational Site Willingboro New Jersey 08046 —
GSK Investigational Site Albuquerque New Mexico 87106 —
GSK Investigational Site Albany New York 12205 —
GSK Investigational Site Binghamton New York 13901 —
GSK Investigational Site Endwell New York 13760 —
GSK Investigational Site Great Neck New York 11023 —
GSK Investigational Site Pittsford New York 14534 —
GSK Investigational Site Pomona New York 10970 —
GSK Investigational Site Cary North Carolina 27511 —
GSK Investigational Site Charlotte North Carolina 28262 —
GSK Investigational Site Gastonia North Carolina 28054 —
GSK Investigational Site Greensboro North Carolina 27403 —
GSK Investigational Site Greenville North Carolina 27858 —
GSK Investigational Site Jacksonville North Carolina 28546 —
GSK Investigational Site Raleigh North Carolina 27609 —
GSK Investigational Site Wilmington North Carolina 28401 —
GSK Investigational Site Wilmington North Carolina 28412 —
GSK Investigational Site Winston-Salem North Carolina 27103 —
GSK Investigational Site Bellbrook Ohio 45305 —
GSK Investigational Site Cincinnati Ohio 45236 —
GSK Investigational Site Columbus Ohio 43207 —
GSK Investigational Site Columbus Ohio 43215 —
GSK Investigational Site Wandsworth Ohio 44281 —
GSK Investigational Site Oklahoma City Oklahoma 73112 —
GSK Investigational Site Tulsa Oklahoma 74135 —
GSK Investigational Site Portland Oregon 97210 —
GSK Investigational Site Portland Oregon 97225 —
GSK Investigational Site Bensalem Pennsylvania 19020 —
GSK Investigational Site Duncansville Pennsylvania 16635 —
GSK Investigational Site Feasterville Pennsylvania 19053 —
GSK Investigational Site Levittown Pennsylvania 19057 —
GSK Investigational Site Media Pennsylvania 19063 —
GSK Investigational Site Morrisville Pennsylvania 19067 —
GSK Investigational Site Penndel Pennsylvania 19047 —
GSK Investigational Site Philadelphia Pennsylvania 19106 —
GSK Investigational Site Philadelphia Pennsylvania 19107 —
GSK Investigational Site Philadelphia Pennsylvania 19148 —
GSK Investigational Site Pittsburgh Pennsylvania 15218 —
GSK Investigational Site Reading Pennsylvania 19611 —
GSK Investigational Site Sellersville Pennsylvania 18960 —
GSK Investigational Site Stoneboro Pennsylvania 16153 —
GSK Investigational Site Anderson South Carolina 29621 —
GSK Investigational Site Charleston South Carolina 29407 —
GSK Investigational Site Summerville South Carolina 29485 —
GSK Investigational Site Sioux Falls South Dakota 57105 —
GSK Investigational Site Bristol Tennessee 37620 —
GSK Investigational Site Clarksville Tennessee 37043 —
GSK Investigational Site Jackson Tennessee 38305 —
GSK Investigational Site Johnson City Tennessee 37601 —
GSK Investigational Site Kingsport Tennessee 37660 —
GSK Investigational Site Knoxville Tennessee 37920 —
GSK Investigational Site Memphis Tennessee 38119 —
GSK Investigational Site Nashville Tennessee 37205 —
GSK Investigational Site Austin Texas 78758 —
GSK Investigational Site Conroe Texas 77304 —
GSK Investigational Site Dallas Texas 75230 —
GSK Investigational Site Houston Texas 77024 —
GSK Investigational Site Humble Texas 77338 —
GSK Investigational Site North Richland Hills Texas 76180 —
GSK Investigational Site Pasadena Texas 77505 —
GSK Investigational Site San Antonio Texas 78205 —
GSK Investigational Site San Antonio Texas 78229 —
GSK Investigational Site Sugar Land Texas 77478 —
GSK Investigational Site The Woodlands Texas 77381 —
GSK Investigational Site Salt Lake City Utah 84132 —
GSK Investigational Site Chesapeake Virginia 23320 —
GSK Investigational Site Christiansburg Virginia 24073 —
GSK Investigational Site Danville Virginia 24541 —
GSK Investigational Site Norfolk Virginia 23502 —
GSK Investigational Site Norfolk Virginia 23507 —
GSK Investigational Site Richmond Virginia 23294 —
GSK Investigational Site Virginia Beach Virginia 23455 —
GSK Investigational Site Weber City Virginia 24290 —
GSK Investigational Site Bellevue Washington 98004 —
GSK Investigational Site Gig Harbor Washington 98335 —
GSK Investigational Site Lacey Washington 98516 —
GSK Investigational Site Tacoma Washington 98405 —
GSK Investigational Site La Crosse Wisconsin 54601 —
GSK Investigational Site Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00067457, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 16, 2015 · Synced Oct 24, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00067457 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →