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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
700
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
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
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Huntsville, Alabama, United States
GSK Investigational Site
Mobile, Alabama, United States
GSK Investigational Site
Pell City, Alabama, United States
GSK Investigational Site
Tallassee, Alabama, United States
GSK Investigational Site
Tucson, Arizona, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
North Little Rock, Arkansas, United States
GSK Investigational Site
Beverly Hills, California, United States
...and 181 more locations