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Irritable ColonPhase 3NCT00067561

Study Of 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 178 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 different doses of an investigational medication in 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
702 participants
Where
178 sitesin 2 countries
Study dates
Jun 2003to Jan 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

178 sites in 2 countries.

178 sites in 2 countries

United States177 sites

  • GSK Investigational Site

    Akron, Ohio, 44302

  • GSK Investigational Site

    Alexandria, Virginia, 22304

  • GSK Investigational Site

    Altoona, Pennsylvania, 16602

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Arlington, Texas, 76012

  • GSK Investigational Site

    Asheville, North Carolina, 28801

  • GSK Investigational Site

    Atlanta, Georgia, 30309

  • GSK Investigational Site

    Atlanta, Georgia, 30328

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Attleboro, Massachusetts, 2703

  • GSK Investigational Site

    Austell, Georgia, 30106

  • GSK Investigational Site

    Austin, Texas, 78745

  • GSK Investigational Site

    Baltimore, Maryland, 21215

  • GSK Investigational Site

    Bay Shore, New York, 11706

  • GSK Investigational Site

    Beavercreek, Ohio, 45431

  • GSK Investigational Site

    Birmingham, Alabama, 35235

  • GSK Investigational Site

    Bismarck, North Dakota, 58501

  • GSK Investigational Site

    Bloomfield, New Jersey, 07003

  • GSK Investigational Site

    Boca Raton, Florida, 33486

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boston, Massachusetts, 02215

  • GSK Investigational Site

    Boulder, Colorado, 80304

  • GSK Investigational Site

    Bountiful, Utah, 84010

  • GSK Investigational Site

    Bowling Green, Kentucky, 42101

  • GSK Investigational Site

    Boynton Beach, Florida, 33426

  • GSK Investigational Site

    Boynton Beach, Florida, 33437

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Calera, Alabama, 35040

  • GSK Investigational Site

    Cary, North Carolina, 27511

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599

  • GSK Investigational Site

    Charlotte, North Carolina, 28207

  • GSK Investigational Site

    Charlottesville, Virginia, 22908

  • GSK Investigational Site

    Charlottesville, Virginia, 22911

  • GSK Investigational Site

    Chaska, Minnesota, 55318

  • GSK Investigational Site

    Chesapeake, Virginia, 23320

  • GSK Investigational Site

    Chula Vista, California, 91910

  • GSK Investigational Site

    Cincinnati, Ohio, 45219

  • GSK Investigational Site

    Cincinnati, Ohio, 45220

  • GSK Investigational Site

    Cincinnati, Ohio, 45224

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Cleveland, Ohio, 44113

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Colorado Springs, Colorado, 80909

  • GSK Investigational Site

    Columbia, South Carolina, 29240

  • GSK Investigational Site

    Columbus, Ohio, 43212

  • GSK Investigational Site

    Coral Gables, Florida, 33134

  • GSK Investigational Site

    Corpus Christi, Texas, 78412

  • GSK Investigational Site

    Dallas, Texas, 75204

  • GSK Investigational Site

    Davenport, Louisiana, 52807

  • GSK Investigational Site

    Dayton, Ohio, 45440

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    East Providence, Rhode Island, 02914

  • GSK Investigational Site

    Egg Harbor, New Jersey, 08234

  • GSK Investigational Site

    Englewood, Colorado, 80113

  • GSK Investigational Site

    Farmington, New Mexico, 87401

  • GSK Investigational Site

    Fayetteville, Arkansas, 72701

  • GSK Investigational Site

    Fayetteville, North Carolina, 28304

  • GSK Investigational Site

    Fleetwood, Pennsylvania, 19522

  • GSK Investigational Site

    Fort Myers, Florida, 33907

  • GSK Investigational Site

    Fort Myers, Florida, 33916

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Garden Grove, California, 92840

  • GSK Investigational Site

    Grand Rapids, Michigan, 49546

  • GSK Investigational Site

    Great Neck, New York, 11023

  • GSK Investigational Site

    Greenville, North Carolina, 27858

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Hershey, Pennsylvania, 17033

  • GSK Investigational Site

    Hialeah, Florida, 33013

  • GSK Investigational Site

    Hickory, North Carolina, 28601

  • GSK Investigational Site

    High Point, North Carolina, 27262

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Houston, Texas, 77024

  • GSK Investigational Site

    Houston, Texas, 77025

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Humble, Texas, 77338

  • GSK Investigational Site

    Indianapolis, Indiana, 46250

  • GSK Investigational Site

    Indianapolis, Indiana, 46254

  • GSK Investigational Site

    Irving, Texas, 75061

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Jefferson City, Missouri, 65101

  • GSK Investigational Site

    Jefferson City, Missouri, 65109

  • GSK Investigational Site

    Kansas City, Missouri, 64131

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Lacey, Washington, 98516

  • GSK Investigational Site

    Lake Worth, Florida, 33461

  • GSK Investigational Site

    Lancaster, California, 93534

  • GSK Investigational Site

    Lancaster, Pennsylvania, 19096

  • GSK Investigational Site

    Laurel, Maryland, 20707

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Longwood, Florida, 32779

  • GSK Investigational Site

    Los Angeles, California, 90045

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Lyndhurst, Ohio, 44124

  • GSK Investigational Site

    Madisonville, Kentucky, 42431

  • GSK Investigational Site

    Manchester, Connecticut, 06040

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Martinez, Georgia, 30907

  • GSK Investigational Site

    Medford, Oregon, 97504

  • GSK Investigational Site

    Memphis, Tennessee, 38119

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Merrick, New York, 11566

  • GSK Investigational Site

    Miami, Florida, 33156

  • GSK Investigational Site

    Miami, Florida, 33186

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53209-0996

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53212

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Missoula, Montana, 59802

  • GSK Investigational Site

    Morehead City, North Carolina, 28557

  • GSK Investigational Site

    Murfreesboro, Tennessee, 37130

  • GSK Investigational Site

    Naples, Florida, 34102

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Port Richey, Florida, 34652

  • GSK Investigational Site

    Newport Beach, California, 92663

  • GSK Investigational Site

    Newtown, Pennsylvania, 18940

  • GSK Investigational Site

    Oak Park, Michigan, 48237

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Ocean City, New Jersey, 7712

  • GSK Investigational Site

    Ogden, Utah, 84405

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73112

  • GSK Investigational Site

    Overland Park, Kansas, 66211

  • GSK Investigational Site

    Panama City, Florida, 32405

  • GSK Investigational Site

    Peoria, Illinois, 61602

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Rancho Cucamonga, California, 91730

  • GSK Investigational Site

    Redlands, California, 92373

  • GSK Investigational Site

    Riverside, Illinois, 60546

  • GSK Investigational Site

    Rochester, New York, 14607

  • GSK Investigational Site

    Saint Joseph, Michigan, 49085

  • GSK Investigational Site

    Saint Paul, Minnesota, 55435

  • 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, 92123

  • GSK Investigational Site

    San Rafael, California, 94901

  • GSK Investigational Site

    Santa Ana, California, 92704

  • GSK Investigational Site

    Santa Ana, California, 92705

  • GSK Investigational Site

    Sarasota, Florida, 34232

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Silver Spring, Maryland, 20901

  • GSK Investigational Site

    Silver Spring, Maryland, 20910

  • GSK Investigational Site

    Simpsonville, South Carolina, 29681

  • GSK Investigational Site

    South Bend, Indiana, 46601

  • GSK Investigational Site

    Spokane, Washington, 99207

  • GSK Investigational Site

    St. Petersburg, Florida, 33702

  • GSK Investigational Site

    Stony Brook, New York, 11794-8091

  • GSK Investigational Site

    Sugar Land, Texas, 77478

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tallahassee, Florida, 32308

  • GSK Investigational Site

    Tampa, Florida, 33614

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Tucson, Arizona, 85723

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35406

  • GSK Investigational Site

    Upland, California, 91786

  • GSK Investigational Site

    Vineland, New Jersey, 8360

  • GSK Investigational Site

    Vista, California, 92084

  • GSK Investigational Site

    Walla Walla, Washington, 99362

  • GSK Investigational Site

    Warren, Michigan, 48089

  • GSK Investigational Site

    Wenatchee, Washington, 98801

  • GSK Investigational Site

    Wentzville, Minnesota, 62285

  • GSK Investigational Site

    West Caldwell, New Jersey, 7006

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

  • GSK Investigational Site

    Wyomissing, Pennsylvania, 19610

  • GSK Investigational Site

    Yakima, Washington, 98902

  • GSK Investigational Site

    Yuba City, California, 95991

  • 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 Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects With Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy

The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.

Being tested
Alosetron
Keywords
Dose-ranging, Diarrhea-Predominant Irritable Bowel Syndrome, d-IBS, IBS, Irritable Bowel Syndrome
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.

Secondary outcomes (1)

  1. Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.

Timeline

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

  1. First posted25 Aug 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionJan 2005
  4. Study completionJan 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
702 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00067561
Sponsor's protocol ID
S3B30040
Status last verified
Apr 2015
First submitted
21 Aug 2003
Last updated
16 Apr 2015
Results posted
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 178 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 178 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.. 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 NCT00067561.

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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