Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy
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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.
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
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
Resource links provided by the National Library of Medicine
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 Measures :
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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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
Failed conventional therapy.
Willing to make daily calls on a touch-tone telephone.
History of or current chronic or severe constipation.
Bloody diarrhea, abdominal pain with rectal bleeding.
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.