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

This study has been completed.

First Received: August 20, 2003 Last Updated: May 15, 2009 History of Changes

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

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 (IBS)	Drug: alosetron	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, 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

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea

Drug Information available for: Alosetron Alosetron hydrochloride

U.S. FDA Resources

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

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	S3B30048
Study First Received:	August 20, 2003
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00067457 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Irritable Bowel Syndrome (IBS)
Diarrhea-Predominant Irritable Bowel Syndrome
PRN

Additional relevant MeSH terms:

Neurotransmitter Agents
Diarrhea
Disease
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Gastrointestinal Agents
Intestinal Diseases
Pharmacologic Actions

Alosetron
Signs and Symptoms
Serotonin Antagonists
Serotonin Agents
Digestive System Diseases
Pathologic Processes
Therapeutic Uses
Syndrome
Irritable Bowel Syndrome
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on November 22, 2009