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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00376896 |
This is a three-period crossover study to compare GW876008 and placebo to see if GW876008 will normalise blood flow responses after different emotional stimuli.
Condition | Intervention | Phase |
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Irritable Bowel Syndrome (IBS) |
Drug: GW876008 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Phase IIa Experimental Medicine Study Assessing Alterations in Regional Cerebral Blood Flow by Functional Magnetic Resonance Imaging (fMRI) in Female IBS Patients and Healthy Controls Following Single Doses of GW876008, a Corticotrophin Releasing Factor 1 Receptor Antagonist (CRF1-RA) |
Estimated Enrollment: | 40 |
Study Start Date: | November 2006 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CRI103147 |
Study First Received: | September 13, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00376896 |
Health Authority: | United States: Food and Drug Administration |
IBS
fMRI |
Digestive System Diseases Corticotropin-Releasing Hormone Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome |
Healthy Intestinal Diseases Colonic Diseases, Functional Adrenocorticotropic Hormone |
Pathologic Processes Disease Syndrome Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |