Clinical Trial: Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 S

Brief Summary: The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Irritable Bowel Syndrome.

Detailed Summary:

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.

Sponsor: Avera Pharmaceuticals

Current Primary Outcome: 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.

Original Primary Outcome: Same as current

Current Secondary Outcome: 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.

Original Secondary Outcome: Same as current

Information By: Avera Pharmaceuticals

Dates:
Date Received: April 19, 2006
Date Started: April 2006
Date Completion:
Last Updated: February 15, 2008
Last Verified: February 2008