Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00067457 |
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 |
Enrollment: | 702 |
Study Start Date: | June 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | S3B30048 |
Study First Received: | August 20, 2003 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00067457 |
Health Authority: | United States: Food and Drug Administration |
Irritable Bowel Syndrome (IBS) Diarrhea-Predominant Irritable Bowel Syndrome PRN |
Alosetron Digestive System Diseases Diarrhea Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional Serotonin |
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 |