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Clotrimazole Enemas for Pouchitis in Children and Adults

Information source: FDA Office of Orphan Products Development
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis; Pouchitis; Ileitis; Inflammatory Bowel Disease

Intervention: Clotrimazole (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: FDA Office of Orphan Products Development

Official(s) and/or principal investigator(s):
Paul A. Rufo, MD, MMSc, Principal Investigator, Affiliation: Children's Hospital and Harvard Medical School

Overall contact:
Paul A. Rufo, MD, MMSc, Phone: 617-355-6058, Email: paul.rufo@tch.harvard.edu


Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients with ulcerative colitis that is resistant to existing medical therapies. The development of inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the most common long-term complication of this procedure and can affect 50-60% of adults and children. We have previously demonstrated that clotrimazole (delivered as a rectal suppository) is generally safe, effective, and displays poor systemic absorption when used in pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch disease that had previously failed to respond to standard antibiotic, steroid, or immunosuppressive therapies. The clinical trial outlined here will define the effectiveness and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged greater than two years) and adult patients with pouchitis. Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to continue their existing anti-inflammatory medications during their participation in the study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy, and pouch disease activity will be graded at after each procedure using the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole treatment group is not significant, and no subject experiences what are determined to be study-related adverse effects, a second cohort of subjects will be recruited and studied after receiving one month of either placebo (4 subjects), 6000 mg/day clotrimazole (8 subjects), or 7500mg/day clotrimazole (8 subjects). Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole blood levels will be measured during the first and last day of study participation. In addition, adults will complete a health related quality of life assessment at baseline and after completing study drug therapy. All subjects will be eligible for one month of open-label study drug therapy after completing one month of study drug therapy.

Clinical Details

Official title: Clotrimazole Enemas for Pouchitis in Children and Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Improvement in Pouchitis Disease Activity Index (PDAI)


Minimum age: 2 Years. Maximum age: N/A. Gender(s): Both.


- Age greater than 2 years

- Availability of Parent or Legal Guardian (for those less than 2 years of age).

- History of ulcerative colitis treated with colectomy and ileal pouch

- Diagnosis of acute or chronic pouchitis

Locations and Contacts

Paul A. Rufo, MD, MMSc, Phone: 617-355-6058, Email: paul.rufo@tch.harvard.edu

Children's Hospital, Boston, Massachusetts 02115, United States; Recruiting
Paul A. Rufo, MD, MMSc, Phone: 617-355-6058, Email: paul.rufo@tch.harvard.edu
Thomas R. Walker, MD, Phone: 617-355-6256, Email: thomas.walker@tch.harvard.edu
Paul A. Rufo, MD, MMSc, Principal Investigator
Thomas R. Walker, M.D., Sub-Investigator
Alan Leichtner, M.D., Sub-Investigator
Additional Information

Crohn's and Colitis Foundation of America

Starting date: September 2002
Last updated: September 19, 2007

Page last updated: August 23, 2015

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