Brain Imaging and Pain in Irritable Bowel Syndrome - Tabular View

Tracking Information

First Received Date ^ICMJE

July 31, 2003

Last Updated Date

August 4, 2008

Start Date ^ICMJE

September 2003

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00065754 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Brain Imaging and Pain in Irritable Bowel Syndrome

Official Title ^ICMJE

Brain Imaging and Pain: Analysis of Placebo Analgesia

Brief Summary

This study examines the mechanisms, including brain imaging of placebo analgesia

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double-Blind, Factorial Assignment

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2007

Primary Completion Date

December 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

Irritable Bowel Syndrome
English speaking

Exclusion criteria:

Chronic pain condition other than Irritable Bowel Syndrome
Medical condition that would contraindicate use of lidocaine
Clinical criteria for fibromyalgia
Presence of systemic disease such as diabetes, thyroid, gastrointestinal or liver disease, collagen vascular disease, malignancy, focal or neurological
Seropositive HIV
Pregnancy

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00065754

Responsible Party

Study ID Numbers ^ICMJE

R01 AT001424-01

Study Sponsor ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Michael E Robinson, PhD

University of Florida

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP