Status:
COMPLETED
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is being done to collect new information on irritable bowel syndrome, a disease that causes abdominal pain that does get better with treatment or keeps coming back ("chronic"). To better un...
Detailed Description
Irritable Bowel Syndrome (IBS) is a common gastrointestinal disorder characterized by chronic abdominal pain and altered bowel function (diarrhea and/or constipation) that effects up to 20% of the Uni...
Eligibility Criteria
Inclusion
- Premenopausal women age 18 years or older OR healthy controls
- Patients with diarrhea predominant IBS that meet the \*Rome II criteria
- The subject must speak English and be able to give informed consent
- All subjects will be tested in the follicular stage of the menstrual cycle as determined by menstrual history and urine testing
- Functional Bowel Disorder Severity Index score of none (0 points) for controls and moderate (37-110 points) for IBS patients
- Normal baseline EKG
Exclusion
- Subject is currently participating in another research protocol that could interfere or influence the outcome measures of the present study
- Subject is unable to give informed consent
- A medical condition that would contraindicate the use of lidocaine (i.e., amide allergy) or a previous history of an abnormal EKG
- Subjects with a positive pregnancy test will be excluded because the use of lidocaine is contraindicated in pregnant women
- Subject is currently taking pain medications, NSAIDs, antihistaminics, antidepressants (tricyclic antidepressants \[TCA\]/selective serotonin reuptake inhibitors \[SSRI\]), anti-convulsants, migraine medications, and cough suppressants
- Presence of systemic disease: diabetes, thyroid disease, gastrointestinal/liver disease (other than IBS), collagen vascular disease, focal or systemic neurological disease, malignancy, seropositive for HIV, or documented psychiatric disorders
- Presence of any chronic pain condition including fibromyalgia
- Subject drinks \> 2 oz. alcohol/day on a regular basis
- Presence of large, palpable hemorrhoids on digital rectal exam that may alter rectal lidocaine adherence to rectal wall
- Abnormal baseline EKG
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108446
Start Date
October 1 2003
End Date
March 1 2006
Last Update
January 21 2009
Active Locations (1)
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1
Malcom Randall VAMC
Gainesville, Florida, United States, 32608