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Phase 3
18 Years
Not Enrolling

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Trial Information

Inclusion Criteria:

(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 Criteria:(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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Bo Shen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:

R03 DK67275 (completed 2007)



Start Date:

Completion Date:

December 2007

Related Keywords:

  • Pouchitis
  • Pouchitis



Cleveland Clinic Foundation Cleveland, Ohio  44195