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

GlaxoSmithKline702 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

702

Conditions

Irritable Colon Irritable Bowel Syndrome (IBS)

Interventions

AlosetronDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (178)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Calera, Alabama, United States

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Chula Vista, California, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Garden Grove, California, United States

GSK Investigational Site

Lancaster, California, United States

...and 168 more locations