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Brain Imaging and Pain in Irritable Bowel Syndrome

This study has been completed.

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00065754
  Purpose

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


Condition Intervention
Irritable Bowel Syndrome
Drug: placebo

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Double-Blind, Factorial Assignment
Official Title:   Brain Imaging and Pain: Analysis of Placebo Analgesia

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

Investigators
Principal Investigator:     Michael E Robinson, PhD     University of Florida    
  More Information


Study ID Numbers:   R01 AT001424-01
First Received:   July 31, 2003
Last Updated:   August 4, 2008
ClinicalTrials.gov Identifier:   NCT00065754
Health Authority:   United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Placebo  
Analgesia  
Pain  
Brain mechanism  
Expectation  

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Irritable Bowel Syndrome
Pain
Intestinal Diseases
Colonic Diseases, Functional

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 17, 2008




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