Status:
COMPLETED
Clinical Approaches to Ileal Pouch Dysfunction
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Pouchitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Total proctocolectomy and ileal pouch-anal anastomosis is the surgical treatment of choice for patients with medically refractory ulcerative colitis, ulcerative colitis with dysplasia or cancer, and p...
Eligibility Criteria
Inclusion
- (must meet ALL of the following criteria);
- Having a history of UC and more than 1 year from TPC/IPAA
- Meet diagnostic criteria of IPS, i.e.
- Symptoms of diarrhea and abdominal pain, with PDAI symptoms score \> (range 2-6).
- Duration of symptoms \> 12 weeks in the preceding 12-months period
- Pouch endoscopy shows no evidence of inflammation of the ileal pouch and rectal cuff
- No antibiotic therapy, aspirin, or non-steriodal anti-inflammatory drugs for 2 weeks prior to entry into the study; no antidepressant and or anti-anxiety medicines for at least 4 weeks.
Exclusion
- (may meet ANY of the following criteria);
- A history of development of side effects from amitriptyline
- IPAA for FAP; celiac disease; chronic pouchitis; Crohn's disease; pouch stricture or anastomotic leak
- Urinary retention, glaucoma, use of MAO inhibitors within past 14 days; acute recovery phase following myocardial infarction; pregnancy
- Psychiatric disorder, including major depression, which requires medical therapy
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00293553
End Date
December 1 2007
Last Update
March 18 2010
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195