Brain Imaging and Pain in Irritable Bowel Syndrome

This study has been completed.

Sponsor:

Collaborators:

National Center for Complementary and Alternative Medicine (NCCAM)

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

University of Florida

ClinicalTrials.gov Identifier:

NCT00065754

First received: July 31, 2003

Last updated: September 16, 2011

Last verified: August 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 31, 2003

Last Updated Date

September 16, 2011

Start Date ^ICMJE

September 2003

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

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

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Drug: placebo

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) 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 Number ^ICMJE

NCT00065754

Other Study ID Numbers ^ICMJE

R01 AT001424-01, R01AT001424-01

Has Data Monitoring Committee

Responsible Party

University of Florida

Study Sponsor ^ICMJE

University of Florida

Collaborators ^ICMJE

National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:

Michael E Robinson, PhD

University of Florida

Information Provided By

University of Florida

Verification Date

August 2011

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

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