Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT00316550|
Recruitment Status : Terminated (Animal Safety Data)
First Posted : April 21, 2006
Last Update Posted : February 25, 2008
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome (IBS)||Drug: AV608||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|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|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||September 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|