Clinical trial NCT00067457: Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Colon
Irritable Bowel Syndrome (IBS)
Keywords: PRN
Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-08-21
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 12 Weeks
Secondary outcomes:
measure: 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.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: GSK Investigational Site
state: Alabama
city: Mobile
country: United States
facility: GSK Investigational Site
state: Alabama
city: Pell City
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tallassee
country: United States
facility: GSK Investigational Site
state: Alabama
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: North Little Rock
country: United States
facility: GSK Investigational Site
state: Arkansas
city: Beverly Hills
country: United States
facility: GSK Investigational Site
state: California
city: Carlsbad
country: United States
facility: GSK Investigational Site
state: California
city: Concord
country: United States
facility: GSK Investigational Site
state: California
city: Encinitas
country: United States
facility: GSK Investigational Site
state: California
city: Fresno
country: United States
facility: GSK Investigational Site
state: California
city: Garden Grove
country: United States
facility: GSK Investigational Site
state: California
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: Orange
country: United States
facility: GSK Investigational Site
state: California
city: Roseville
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: San Francisco
country: United States
facility: GSK Investigational Site
state: California
city: Santa Ana
country: United States
facility: GSK Investigational Site
state: California
city: Spring Valley
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Van Nuys
country: United States
facility: GSK Investigational Site
state: California
city: Centennial
country: United States
facility: GSK Investigational Site
state: Colorado
city: Colorado Springs
country: United States
facility: GSK Investigational Site
state: Colorado
city: Littleton
country: United States
facility: GSK Investigational Site
state: Colorado
city: Longmont
country: United States
facility: GSK Investigational Site
state: Colorado
city: Bristol
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Belleair Bluffs
country: United States
facility: GSK Investigational Site
state: Florida
city: Boca Raton
country: United States
facility: GSK Investigational Site
state: Florida
city: Bradenton
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Clearwater
country: United States
facility: GSK Investigational Site
state: Florida
city: Deland
country: United States
facility: GSK Investigational Site
state: Florida
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
city: Hollywood
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: GSK Investigational Site
state: Florida
city: Melbourne
country: United States
facility: GSK Investigational Site
state: Florida
city: North Miami Beach
country: United States
facility: GSK Investigational Site
state: Florida
city: Spring Hill
country: United States
facility: GSK Investigational Site
state: Florida
city: Stuart
country: United States
facility: GSK Investigational Site
state: Florida
city: Zephyrhills
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: GSK Investigational Site
state: Georgia
city: Dunwoody
country: United States
facility: GSK Investigational Site
state: Georgia
city: Fayetteville
country: United States
facility: GSK Investigational Site
state: Georgia
city: Rome
country: United States
facility: GSK Investigational Site
state: Georgia
city: Savannah
country: United States
facility: GSK Investigational Site
state: Georgia
city: Boise
country: United States
facility: GSK Investigational Site
state: Idaho
city: Coeur D'Alene
country: United States
facility: GSK Investigational Site
state: Idaho
city: Meridian
country: United States
facility: GSK Investigational Site
state: Idaho
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Libertyville
country: United States
facility: GSK Investigational Site
state: Illinois
city: Moline
country: United States
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state: Illinois
city: Morton Grove
country: United States
facility: GSK Investigational Site
state: Illinois
city: Oakbrook Terrace
country: United States
facility: GSK Investigational Site
state: Illinois
city: Peoria
country: United States
facility: GSK Investigational Site
state: Illinois
city: Rockford
country: United States
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state: Illinois
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: GSK Investigational Site
state: Indiana
city: Clive
country: United States
facility: GSK Investigational Site
state: Iowa
city: Haysville
country: United States
facility: GSK Investigational Site
state: Kansas
city: Kansas City
country: United States
facility: GSK Investigational Site
state: Kansas
city: Wichita
country: United States
facility: GSK Investigational Site
state: Kansas
city: Florence
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Lexington
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Madisonville
country: United States
facility: GSK Investigational Site
state: Kentucky
city: Covington
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Lafayette
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Monroe
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: GSK Investigational Site
state: Louisiana
city: Annapolis
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Lanham
country: United States
facility: GSK Investigational Site
state: Maryland
city: Oxon Hill
country: United States
facility: GSK Investigational Site
state: Maryland
city: Severna Park
country: United States
facility: GSK Investigational Site
state: Maryland
city: Silver Spring
country: United States
facility: GSK Investigational Site
state: Maryland
city: Towson
country: United States
facility: GSK Investigational Site
state: Maryland
city: Towson
country: United States
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state: Maryland
city: Wheaton
country: United States
facility: GSK Investigational Site
state: Maryland
city: Burlington
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Farmington Hills
country: United States
facility: GSK Investigational Site
state: Michigan
city: Northville
country: United States
facility: GSK Investigational Site
state: Michigan
city: Petoskey
country: United States
facility: GSK Investigational Site
state: Michigan
city: Saginaw
country: United States
facility: GSK Investigational Site
state: Michigan
city: Brooklyn Center
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: GSK Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: GSK Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: GSK Investigational Site
state: Nevada
city: Berlin
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Blackwood
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Cedar Knolls
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Oakhurst
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Passaic
country: United States
facility: GSK Investigational Site
state: New Jersey
city: South Bound Brook
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Willingboro
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: GSK Investigational Site
state: New Mexico
city: Albany
country: United States
facility: GSK Investigational Site
state: New York
city: Binghamton
country: United States
facility: GSK Investigational Site
state: New York
city: Endwell
country: United States
facility: GSK Investigational Site
state: New York
city: Great Neck
country: United States
facility: GSK Investigational Site
state: New York
city: Pittsford
country: United States
facility: GSK Investigational Site
state: New York
city: Pomona
country: United States
facility: GSK Investigational Site
state: New York
city: Cary
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Gastonia
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Jacksonville
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Bellbrook
country: United States
facility: GSK Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Columbus
country: United States
facility: GSK Investigational Site
state: Ohio
city: Wandsworth
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Portland
country: United States
facility: GSK Investigational Site
state: Oregon
city: Bensalem
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Feasterville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Levittown
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Media
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Morrisville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Penndel
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Reading
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sellersville
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Stoneboro
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Anderson
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Summerville
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Clarksville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Johnson City
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Kingsport
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: GSK Investigational Site
state: Tennessee
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Conroe
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Houston
country: United States
facility: GSK Investigational Site
state: Texas
city: Humble
country: United States
facility: GSK Investigational Site
state: Texas
city: North Richland Hills
country: United States
facility: GSK Investigational Site
state: Texas
city: Pasadena
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: GSK Investigational Site
state: Texas
city: Woodlands
country: United States
facility: GSK Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: GSK Investigational Site
state: Utah
city: Chesapeake
country: United States
facility: GSK Investigational Site
state: Virginia
city: Christiansburg
country: United States
facility: GSK Investigational Site
state: Virginia
city: Danville
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: GSK Investigational Site
state: Virginia
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Virginia Beach
country: United States
facility: GSK Investigational Site
state: Virginia
city: Weber City
country: United States
facility: GSK Investigational Site
state: Virginia
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Washington
city: Gig Harbor
country: United States
facility: GSK Investigational Site
state: Washington
city: Lacey
country: United States
facility: GSK Investigational Site
state: Washington
city: Tacoma
country: United States
facility: GSK Investigational Site
state: Washington
city: La Crosse
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: