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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00067457
First received: August 20, 2003
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Irritable Colon
Irritable Bowel Syndrome (IBS)
Drug: alosetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 702
Study Start Date: June 2003
Intervention Details:
    Drug: alosetron
    Other Name: alosetron
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067457

  Hide Study Locations
Locations
United States, Alabama
GSK Investigational Site
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
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85712
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
United States, California
GSK Investigational Site
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, 94122
GSK Investigational Site
San Francisco, California, United States, 94115
GSK Investigational Site
San Francisco, California, United States, 94114
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
United States, Colorado
GSK Investigational Site
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
United States, Connecticut
GSK Investigational Site
Bristol, Connecticut, United States, 06010
United States, Florida
GSK Investigational Site
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
United States, Georgia
GSK Investigational Site
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
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83702
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
GSK Investigational Site
Meridian, Idaho, United States, 83642
United States, Illinois
GSK Investigational Site
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
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
GSK Investigational Site
Indianapolis, Indiana, United States, 46208
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
United States, Iowa
GSK Investigational Site
Clive, Iowa, United States, 50325
United States, Kansas
GSK Investigational Site
Haysville, Kansas, United States, 67060
GSK Investigational Site
Kansas City, Kansas, United States, 66160
GSK Investigational Site
Wichita, Kansas, United States, 67203
United States, Kentucky
GSK Investigational Site
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
United States, Louisiana
GSK Investigational Site
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, 70128
GSK Investigational Site
New Orleans, Louisiana, United States, 70112
GSK Investigational Site
Shreveport, Louisiana, United States, 71103
United States, Maryland
GSK Investigational Site
Annapolis, Maryland, United States, 21401
GSK Investigational Site
Baltimore, Maryland, United States, 21215
GSK Investigational Site
Baltimore, Maryland, United States, 21229
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
United States, Massachusetts
GSK Investigational Site
Burlington, Massachusetts, United States, 01805
United States, Michigan
GSK Investigational Site
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
United States, Minnesota
GSK Investigational Site
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
GSK Investigational Site
Chesterfield, Missouri, United States, 63017
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68503
GSK Investigational Site
Omaha, Nebraska, United States, 68144
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
United States, New Jersey
GSK Investigational Site
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
United States, New Mexico
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
United States, New York
GSK Investigational Site
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
United States, North Carolina
GSK Investigational Site
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, 28412
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Bellbrook, Ohio, United States, 45305
GSK Investigational Site
Cincinnati, Ohio, United States, 45236
GSK Investigational Site
Columbus, Ohio, United States, 43207
GSK Investigational Site
Columbus, Ohio, United States, 43215
GSK Investigational Site
Wandsworth, Ohio, United States, 44281
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
United States, Oregon
GSK Investigational Site
Portland, Oregon, United States, 97210
GSK Investigational Site
Portland, Oregon, United States, 97225
United States, Pennsylvania
GSK Investigational Site
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, 19106
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
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
United States, South Carolina
GSK Investigational Site
Anderson, South Carolina, United States, 29621
GSK Investigational Site
Charleston, South Carolina, United States, 29407
GSK Investigational Site
Summerville, South Carolina, United States, 29485
United States, South Dakota
GSK Investigational Site
Sioux Falls, South Dakota, United States, 57105
United States, Tennessee
GSK Investigational Site
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
United States, Texas
GSK Investigational Site
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, 78205
GSK Investigational Site
San Antonio, Texas, United States, 78229
GSK Investigational Site
Sugar Land, Texas, United States, 77478
GSK Investigational Site
Woodlands, Texas, United States, 77381
United States, Utah
GSK Investigational Site
Salt Lake City, Utah, United States, 84132
United States, Virginia
GSK Investigational Site
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
United States, Washington
GSK Investigational Site
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
United States, Wisconsin
GSK Investigational Site
La Crosse, Wisconsin, United States, 54601
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 27408
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00067457     History of Changes
Other Study ID Numbers: S3B30048
Study First Received: August 20, 2003
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
PRN
Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS)

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Alosetron
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014