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

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

This study has been completed.
Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

Brief 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.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Irritable Bowel Syndrome

Intervention ^†

Drug: alosetron

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

702

Start Date ^†

June 2003

Completion Date

Eligibility 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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00067457

Organization ID

S3B30048

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

September 2007

First Received Date ^†

August 20, 2003

Last Updated Date

September 24, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.