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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00370032 |
This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS) patients.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome (IBS) |
Drug: alosetron |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Randomize, Placebo-Controlled, Crossover Study to Measure the Effect of Alosetron on Mucosal Blood Flow in Female Healthy Volunteers and Diarrhea-Predominant IBS Subjects |
Enrollment: | 49 |
Study Start Date: | December 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
The subject is female and either:
The subject demonstrates a negative urine pregnancy test result prior to investigational product administration and be either:
Exclusion criteria:
Evidence of a biochemical or structural abnormality of the digestive tract. These conditions include (but not limited to):
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | S3B40042 |
Study First Received: | August 28, 2006 |
Results First Received: | December 19, 2008 |
Last Updated: | April 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00370032 History of Changes |
Health Authority: | United States: Food and Drug Administration |
mucosal blood flow
d-IBS |
Alosetron Neurotransmitter Agents Digestive System Diseases Diarrhea Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Healthy Intestinal Diseases Colonic Diseases, Functional Serotonin |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Physiological Effects of Drugs Colonic Diseases Gastrointestinal Agents Intestinal Diseases Pharmacologic Actions |
Alosetron Serotonin Antagonists Digestive System Diseases Serotonin Agents Therapeutic Uses Irritable Bowel Syndrome Colonic Diseases, Functional |