Study In Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy - Full Text View

Purpose

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.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: alosetron	Phase III

MedlinePlus related topics:

Diarrhea

ChemIDplus related topics:

Alosetron Alosetron hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ]

Enrollment:	702
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067457

Show 194 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Study ID Numbers:	S3B30048
First Received:	August 20, 2003
Last Updated:	September 24, 2007
ClinicalTrials.gov Identifier:	NCT00067457
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Irritable Bowel Syndrome (IBS)

Diarrhea-Predominant Irritable Bowel Syndrome

PRN

Study placed in the following topic categories:

Alosetron

Digestive System Diseases

Diarrhea

Gastrointestinal Diseases

Colonic Diseases

Irritable Bowel Syndrome

Intestinal Diseases

Colonic Diseases, Functional

Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents

Serotonin Antagonists

Serotonin Agents

Pathologic Processes

Disease

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Syndrome

Physiological Effects of Drugs

Gastrointestinal Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 18, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00067457