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Sponsors and Collaborators: |
Avera Pharmaceuticals University of California, Los Angeles |
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Information provided by: | Avera Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00316550 |
The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.
Condition | Intervention | Phase |
---|---|---|
Irritable Bowel Syndrome (IBS) |
Drug: AV608 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Pilot Study to Assess the Effects of AV608 on Central Processing of Visceral Stimuli in Subjects With Irritable Bowel Syndrome |
Estimated Enrollment: | 24 |
Study Start Date: | April 2006 |
Study Completion Date: | September 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
This is a single-center, randomized, double-blind, placebo-controlled, cross-over study to assess the effects of AV608 on brain processing of visceral stimuli and emotional visual cues in subjects with IBS. Female subjects between 18 and 65 years of age who meet diagnostic criteria for Irritable Bowel Syndrome will be eligible for the study.
Eligible subjects will complete a baseline fMRI imaging procedure that includes both emotional visual cues and visceral stimulation. All subjects who participate in the study will receive 3 weeks of treatment with AV608 and 3 weeks of treatment with placebo during the course of the study; the order of the two treatments for each subject will be randomly determined.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA Center for Neurovisceral Sciences and Women's Health | |
Los Angeles, California, United States, 90095 |
Study Director: | Joao Siffert, MD | Avera Pharmaceuticals, Inc. |
Principal Investigator: | Kirsten Tillisch, MD | UCLA Center for Neurovisceral Sciences and Women's Health |
Study ID Numbers: | AV608-107 |
Study First Received: | April 19, 2006 |
Last Updated: | February 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00316550 |
Health Authority: | United States: Food and Drug Administration |
Irritable Bowel Syndrome (IBS) |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Irritable Bowel Syndrome Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |