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

Irritable Bowel Syndrome (IBS) Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

• NCT number: NCT00316550
• Study type: Interventional
• Source: Avera Pharmaceuticals
• Status: Terminated
• Phase: Phase 1
• Start date: April 2006
• Completion date: September 2007