Status:
COMPLETED
Gastrointestinal Biopsychosocial Research Center
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
University of North Carolina, Chapel Hill
Conditions:
Chronic Proctalgia (Also Called Levator Ani Syndrome)
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study has been completed. The following is a brief description of the aims, methods, and results of the study: Previous small studies suggest that chronic proctalgia (chronic recurring pain in t...
Eligibility Criteria
Inclusion
- Recurring episodes of pain or aching in the anal canal or rectum for at least 12 weeks in the previous year. Episodes last at least 20 minutes. Pain must occur at least weekly during a 4-week run-in.
Exclusion
- Other medical or psychiatric diagnoses that could explain recurring rectal pain. Daily use of psychotropic medications. Meets diagnostic criteria for irritable bowel syndrome or functional constipation. Screening studies included physical examination by a gastroenterologist, colonoscopy, pelvic ultrasound, and surgical consult in all patients and referral to a gynecologist or urologist if indicated by history.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00947180
Start Date
October 1 2000
End Date
December 1 2007
Last Update
October 18 2017
Active Locations (1)
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1
Division of Gastroenterology at the University of Verona
Verona, Italy