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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Irritable Colon; Irritable Bowel Syndrome (IBS)

Intervention: Alosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

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.

Clinical Details

Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

GSK Investigational Site, Birmingham, Alabama 35235, United States

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GSK Investigational Site, Milwaukee, Wisconsin 53212, United States

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Additional Information

Starting date: June 2003
Last updated: April 15, 2015

Page last updated: August 23, 2015

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