Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-01-02 @ 1:26 PM
Study NCT ID:
NCT00316550
Status:
TERMINATED
Last Update Posted:
2008-02-25
First Post:
2006-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome
Sponsor:
Avera Pharmaceuticals
Organization:
Study Overview
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
Status Verified Date:
2008-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Animal Safety Data
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: