Back to resultsCharacterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Viceral Perception Testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Visceral Hypersensitivity, Visceral Pain
Eligibility Criteria
Patients with irritable bowel syndrome and healthy pain-free individuals (as controls) will be studied. No medical condition that would contraindicate use of dextromethorphan, fentanyl or naloxone.
Sites / Locations
- Malcolm Randall VA Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00100425
First Posted
December 30, 2004
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00100425
Brief Title
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Official Title
Central Nervous System Modulation of Visceral Pain in Persian Gulf War Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to provide new information and to determine which kinds of brief, tolerable, experimental pain are affected by the drugs being studied in patients with irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these studies to better understand what causes irritable bowel syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Visceral Hypersensitivity, Visceral Pain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Viceral Perception Testing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients with irritable bowel syndrome and healthy pain-free individuals (as controls) will be studied.
No medical condition that would contraindicate use of dextromethorphan, fentanyl or naloxone.
Facility Information:
Facility Name
Malcolm Randall VA Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
12. IPD Sharing Statement
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Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
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