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Birmingham, Alabama 35235

  • Irritable Bowel Syndrome (IBS)


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.


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.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

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

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 Therap

Overall Status:


Study Phase:

Phase 3



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:


Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification: S

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director

Study Dates

Start Date:June 2003
Completion Date:January 2005
Completion Type:Actual
Primary Completion Date:January 2005
Primary Completion Type:Actual
Verification Date:April 2015
Last Changed Date:April 15, 2015
First Received Date:August 21, 2003

Study Outcomes

Outcome Type: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.
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
Safety Issues:False

Study Interventions

Intervention Type:Drug
Other Name:Alosetron

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:GlaxoSmithKline

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: March 30, 2020

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