Pilot Study to Assess the Effects of AV608 on Irritable Bowel Syndrome - Full Text View

Sponsors and Collaborators:	Avera Pharmaceuticals University of California, Los Angeles
Information provided by:	Avera Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00316550

Purpose

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

Condition	Intervention	Phase
Irritable Bowel Syndrome (IBS)	Drug: AV608	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Avera Pharmaceuticals:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	24
Study Start Date:	April 2006
Study Completion Date:	September 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female, 18 to 65 years of age, inclusive
Current diagnosis of Irritable Bowel Syndrome (IBS)
Subjects 50 years of age or older must have had a barium enema and flexible sigmoidoscopy or a colonoscopy and provide a record of this test
Willing to participate in this study as evidenced by a signed, written informed consent form (ICF)
If female and of child-bearing potential, willing to avoid pregnancy and practice adequate birth control from the time of study enrollment through at least 30 days after the final dose of study medication
If female, negative pregnancy test results
Right handed
Ambulatory outpatient
Agrees to refrain from blood donation during the course of the study
Written and oral fluency in the English language

Exclusion Criteria:

Evidence of structural abnormality of the gastrointestinal tract or GI diseases/conditions
Current evidence or diagnosis of peptic ulcer
Endoscopic bowel evaluation with evidence of cancer, inflammatory bowel disease, or other structural disease
History of abdominal surgery such as adhesion lysis or any gastrointestinal surgery
History of gastroesophageal reflux disease not controlled by a stable dose of medication
Any evidence of or treatment of malignancy within the previous 5 years
Clinical evidence of any disease that may interfere with participation in the study
Existence of surgical or medical conditions which interfere with the absorption, distribution, metabolism and excretion of the study drug
Symptoms of a significant clinical illness within the 2 weeks prior to Screening
Type 1 diabetes mellitus, insulin-dependent Type 2 diabetes mellitus, and thyroid disorders or other endocrine disorders that are not well controlled by appropriate therapy
A QTc interval of greater than or equal to 450 msec at Screening
Presence of a psychotic disorder, bipolar disorder, alcohol or substance dependence (other than nicotine dependence) or eating disorder within the previous year according to DSM-IV-TR criteria
Seizure disorder
Subjects who have previously participated in a clinical trial for AV608 (previously known as NKP608 and CGP608)
Positive drug test result at Screening
Use of investigational drugs, products or devices within 30 days prior to Screening
Planned use of certain drugs during the study that affect the central nervous system, gastrointestinal motility, autonomic activity or pain sensation
Use of pimozide, terfenadine, astemizole, or cisapride during the study
Presence of moderate or severe allergy
Regular intake of more than 2 units of alcohol per day
Pregnant or breast feeding
Subjects with morbid obesity
Subjects with metal implants or large tattoo
Any clinically significant abnormalities on the Screening physical examination, ECG or laboratory tests
Members of the investigative staff or their immediate family members
Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol
Regular use of more than 10 cigarettes per day

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00316550

Locations

United States, California
UCLA Center for Neurovisceral Sciences and Women's Health
Los Angeles, California, United States, 90095

Sponsors and Collaborators

Avera Pharmaceuticals

University of California, Los Angeles

Investigators

Study Director:	Joao Siffert, MD	Avera Pharmaceuticals, Inc.
Principal Investigator:	Kirsten Tillisch, MD	UCLA Center for Neurovisceral Sciences and Women's Health

More Information

Study ID Numbers:	AV608-107
Study First Received:	April 19, 2006
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00316550
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avera Pharmaceuticals:

Irritable Bowel Syndrome (IBS)

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases

Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009