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 Therap

Purpose:

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.

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.

NCT ID:

NCT00067561

Primary Contact:

Study Director
GSK Clinical Trials
GlaxoSmithKline

Backup Contact:

N/A

Location Contact:

Garden Grove, California 92840
United States



There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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