NCT00316550

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Avera Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Irritable Bowel Syndrome (IBS)

Interventions

Type	Name	Description
DRUG	AV608

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-06-01
• Completion: 2007-09-01
• First posted: 2006-04-21
• Last updated: 2008-02-25

Locations

1 site across 1 country: United States