Study Of 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 different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
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 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.
Secondary Outcome Measures :
Comparison of treatment groups with respect to subject relief of IBS pain & discomfort.
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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.