Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|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|
- The primary efficacy endpoint is the effect of AV608 on regional brain responses as measured by fMRI during conditioned and unconditioned visceral pain due to rectal distension.
- The effect of AV608 on regional brain responses to emotional visceral cues as measured by fMRI and the visceral pain threshold during rectal distension will be evaluated as secondary efficacy endpoints.
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316550
|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|