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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
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome
 Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Official Title: Brain Imaging and Pain: Analysis of Placebo Analgesia

Further study details as provided by University of Florida:

Estimated Enrollment: 50
Study Start Date: September 2003
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065754

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Michael E Robinson, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00065754     History of Changes
Other Study ID Numbers: R01 AT001424-01, R01AT001424-01
Study First Received: July 31, 2003
Last Updated: September 16, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Florida:
Placebo
Analgesia
Pain
Brain mechanism
Expectation

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013