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Irritable ColonPhase 3NCT00067457

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

A Phase 3 study testing alosetron in people with Irritable Colon and Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 191 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
alosetron
How many people
700 participants
Where
191 sitesin 2 countries
Study dates
Jun 2003to Dec 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
  • Failed conventional therapy.
  • Willing to make daily calls on a touch-tone telephone.

Who cannot join

  • 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.

Trial locations and contacts

191 sites in 2 countries.

191 sites in 2 countries

United States190 sites

  • GSK Investigational Site

    Albany, New York, 12205

  • GSK Investigational Site

    Albuquerque, New Mexico, 87106

  • GSK Investigational Site

    Anderson, South Carolina, 29621

  • GSK Investigational Site

    Annapolis, Maryland, 21401

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Atlanta, Georgia, 30339

  • GSK Investigational Site

    Austin, Texas, 78758

  • GSK Investigational Site

    Baltimore, Maryland, 21215

  • GSK Investigational Site

    Baltimore, Maryland, 21229

  • GSK Investigational Site

    Bellbrook, Ohio, 45305

  • GSK Investigational Site

    Belleair Bluffs, Florida, 33770

  • GSK Investigational Site

    Bellevue, Washington, 98004

  • GSK Investigational Site

    Bensalem, Pennsylvania, 19020

  • GSK Investigational Site

    Berlin, New Jersey, 08009

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Binghamton, New York, 13901

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Birmingham, Alabama, 35242

  • GSK Investigational Site

    Blackwood, New Jersey, 08012

  • GSK Investigational Site

    Blue Ridge, Georgia, 30513

  • GSK Investigational Site

    Boca Raton, Florida, 33428

  • GSK Investigational Site

    Boise, Idaho, 83702

  • GSK Investigational Site

    Bradenton, Florida, 34209

  • GSK Investigational Site

    Bristol, Connecticut, 06010

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Brooklyn Center, Minnesota, 55430

  • GSK Investigational Site

    Burlington, Massachusetts, 01805

  • GSK Investigational Site

    Carlsbad, California, 92008

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Cedar Knolls, New Jersey, 7927

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Charleston, South Carolina, 29407

  • GSK Investigational Site

    Charlotte, North Carolina, 28262

  • GSK Investigational Site

    Chesapeake, Virginia, 23320

  • GSK Investigational Site

    Chesterfield, Missouri, 63017

  • GSK Investigational Site

    Chicago, Illinois, 60612-7323

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Christiansburg, Virginia, 24073

  • GSK Investigational Site

    Cincinnati, Ohio, 45236

  • GSK Investigational Site

    Clarksville, Tennessee, 37043

  • GSK Investigational Site

    Clearwater, Florida, 33756

  • GSK Investigational Site

    Clearwater, Florida, 33765

  • GSK Investigational Site

    Clive, Iowa, 50325

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    Columbus, Ohio, 43207

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Concord, California, 94520

  • GSK Investigational Site

    Conroe, Texas, 77304

  • GSK Investigational Site

    Covington, Louisiana, 70433

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Danville, Virginia, 24541

  • GSK Investigational Site

    DeLand, Florida, 32720

  • GSK Investigational Site

    Duncansville, Pennsylvania, 16635

  • GSK Investigational Site

    Dunwoody, Georgia, 30328

  • GSK Investigational Site

    Encinitas, California, 92024

  • GSK Investigational Site

    Endwell, New York, 13760

  • GSK Investigational Site

    Farmington Hills, Michigan, 48334

  • GSK Investigational Site

    Fayetteville, Georgia, 30214

  • GSK Investigational Site

    Feasterville, Pennsylvania, 19053

  • GSK Investigational Site

    Florence, Kentucky, 41042

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gainesville, Florida, 32607

  • GSK Investigational Site

    Garden Grove, California, 92840

  • GSK Investigational Site

    Gastonia, North Carolina, 28054

  • GSK Investigational Site

    Gig Harbor, Washington, 98335

  • GSK Investigational Site

    Great Neck, New York, 11023

  • GSK Investigational Site

    Greensboro, North Carolina, 27403

  • GSK Investigational Site

    Greenville, North Carolina, 27858

  • GSK Investigational Site

    Haysville, Kansas, 67060

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Humble, Texas, 77338

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Indianapolis, Indiana, 46208

  • GSK Investigational Site

    Indianapolis, Indiana, 46237

  • GSK Investigational Site

    Jackson, Tennessee, 38305

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Jacksonville, Florida, 32256-6004

  • GSK Investigational Site

    Jacksonville, North Carolina, 28546

  • GSK Investigational Site

    Jeffersonville, Indiana, 47130

  • GSK Investigational Site

    Johnson City, Tennessee, 37601

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Kissimmee, Florida, 34741

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    La Crosse, Wisconsin, 54601

  • GSK Investigational Site

    Lacey, Washington, 98516

  • GSK Investigational Site

    Lafayette, Louisiana, 70508

  • GSK Investigational Site

    Lanham, Maryland, 20706

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Levittown, Pennsylvania, 19057

  • GSK Investigational Site

    Lexington, Kentucky, 40508

  • GSK Investigational Site

    Lexington, Kentucky, 40536

  • GSK Investigational Site

    Libertyville, Illinois, 60048

  • GSK Investigational Site

    Lincoln, Nebraska, 68503

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Littleton, Colorado, 80120

  • GSK Investigational Site

    Longmont, Colorado, 80501

  • GSK Investigational Site

    Los Angeles, California, 90035

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Media, Pennsylvania, 19063

  • GSK Investigational Site

    Melbourne, Florida, 32901

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Meridian, Idaho, 83642

  • GSK Investigational Site

    Mobile, Alabama, 36693

  • GSK Investigational Site

    Moline, Illinois, 61265

  • GSK Investigational Site

    Monroe, Louisiana, 71201

  • GSK Investigational Site

    Morrisville, Pennsylvania, 19067

  • GSK Investigational Site

    Morton Grove, Illinois, 61550

  • GSK Investigational Site

    Nashville, Tennessee, 37205

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    New Orleans, Louisiana, 70128

  • GSK Investigational Site

    Norfolk, Virginia, 23502

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    North Little Rock, Arkansas, 72117

  • GSK Investigational Site

    North Miami Beach, Florida, 33162

  • GSK Investigational Site

    North Richland Hills, Texas, 76180

  • GSK Investigational Site

    Northville, Michigan, 48167

  • GSK Investigational Site

    Oakbrook Terrace, Illinois, 60181

  • GSK Investigational Site

    Oakhurst, New Jersey, 07755

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Omaha, Nebraska, 68144

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Oxon Hill, Maryland, 20745

  • GSK Investigational Site

    Pasadena, Texas, 77505

  • GSK Investigational Site

    Passaic, New Jersey, 07055

  • GSK Investigational Site

    Pell City, Alabama, 35125

  • GSK Investigational Site

    Penndel, Pennsylvania, 19047

  • GSK Investigational Site

    Peoria, Illinois, 61602

  • GSK Investigational Site

    Petoskey, Michigan, 49770

  • 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

    Pittsford, New York, 14534

  • GSK Investigational Site

    Pomona, New York, 10970

  • GSK Investigational Site

    Portland, Oregon, 97210

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Richmond, Virginia, 23294

  • GSK Investigational Site

    Rockford, Illinois, 61107

  • GSK Investigational Site

    Rome, Georgia, 30165

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Saginaw, Michigan, 48602

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • 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

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Severna Park, Maryland, 21146

  • GSK Investigational Site

    Shreveport, Louisiana, 71103

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    South Bound Brook, New Jersey, 08880

  • GSK Investigational Site

    Spring Hill, Florida, 34608

  • GSK Investigational Site

    Spring Valley, California, 91978

  • GSK Investigational Site

    St Louis, Missouri, 63141

  • GSK Investigational Site

    Stoneboro, Pennsylvania, 16153

  • GSK Investigational Site

    Stuart, Florida, 34996

  • GSK Investigational Site

    Sugar Land, Texas, 77478

  • GSK Investigational Site

    Summerville, South Carolina, 29485

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tallassee, Alabama, 36078

  • GSK Investigational Site

    The Woodlands, Texas, 77381

  • GSK Investigational Site

    Torrance, California, 90505

  • GSK Investigational Site

    Towson, Maryland, 21204-7736

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Tucson, Arizona, 85712

  • GSK Investigational Site

    Tulsa, Oklahoma, 74135

  • GSK Investigational Site

    Van Nuys, California, 91405

  • GSK Investigational Site

    Virginia Beach, Virginia, 23455

  • GSK Investigational Site

    Wandsworth, Ohio, 44281

  • GSK Investigational Site

    Weber City, Virginia, 24290

  • GSK Investigational Site

    Wheaton, Maryland, 20906

  • GSK Investigational Site

    Wichita, Kansas, 67203

  • GSK Investigational Site

    Willingboro, New Jersey, 08046

  • 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

    Zephyrhills, Florida, 33540

Other trials in United States

Australia1 site

  • GSK Investigational Site

    Nedlands, Western Australia, 27408

Other trials in Australia

About this study

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

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.

Being tested
alosetron
Keywords
PRN, Diarrhea-Predominant Irritable Bowel Syndrome, Irritable Bowel Syndrome (IBS)
Medical subject headings
Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • alosetronDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 Weeks

Secondary outcomes (1)

  1. 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.

    Measured: 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionDec 2005
  4. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067457
Sponsor's protocol ID
S3B30048
Status last verified
Apr 2015
First submitted
20 Aug 2003
Last updated
16 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing alosetron in people with Irritable Colon and Irritable Bowel Syndrome (IBS), run by GlaxoSmithKline at 191 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00067457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.

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