Expired Study
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Phoenix, Arizona 85006


Purpose:

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.


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.


Study is Available At:


Original ID:

S3B30040


NCT ID:

NCT00067561


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:

Completed


Study Phase:

Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

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

Study Source:

GlaxoSmithKline


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

702


Enrollment Type:

Actual


Overall Contact Information

Official Name:GSK Clinical Trials
Study Director
GlaxoSmithKline

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
Name:Alosetron
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: ClinicalTrials.gov

Date Processed: January 21, 2020

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