Status:
COMPLETED
Development of a Questionnaire to Measure Hypervigilance for Visceral Pain
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to develop and validate a questionnaire (non-invasive technique) to identify patients who are hypervigilant for noxious visceral sensations and who show a lower threshold to r...
Detailed Description
Methods: There are two phases to the project: (1) Development of the pool of items (questions), and (2) validating individual items based on their correlation with an objective gold standard - the res...
Eligibility Criteria
Inclusion
- clinical diagnosis of IBS
- meets Rome III criteria for IBS
- women or men aged 18 or older
Exclusion
- use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
- use of analgesics for 48 hours prior to the study
- hypothyroid
- history of bowel resection except appendectomy or cholecystectomy
- psychotic disorder, major depression, substance abuse (other than tobacco)or other psychiatric condition likely to interfere with the conduct of the study
- renal disease
- patients with inflammatory or ischemic disease of the rectum
- known to be unreliable.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01166802
Start Date
February 1 2008
End Date
June 1 2010
Last Update
July 21 2010
Active Locations (1)
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1
UNC Center for Clinical and Translational Research
Chapel Hill, North Carolina, United States, 27599