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Brain Imaging and Pain in Irritable Bowel Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00065754
First Posted: August 1, 2003
Last Update Posted: September 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of Florida
  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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065754


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

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00065754     History of Changes
Other Study ID Numbers: R01AT001424-01 ( U.S. NIH Grant/Contract )
First Submitted: July 31, 2003
First Posted: August 1, 2003
Last Update Posted: September 20, 2011
Last Verified: August 2011

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

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