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Clotrimazole Enemas for Pouchitis in Children and Adults

NCT ID: NCT00061282

Last Updated: 2022-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2020-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Ulcerative Colitis Pouchitis Ileitis Inflammatory Bowel Disease

Keywords

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Pouchitis Colitis Ileitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Clotrimazole

Intervention Type DRUG

One retention enema, administered nightly

2

Clotrimazole Therapy

Group Type ACTIVE_COMPARATOR

Clotrimazole

Intervention Type DRUG

One retention enema, administered nightly

3

Clotrimazole Therapy

Group Type ACTIVE_COMPARATOR

Clotrimazole

Intervention Type DRUG

One retention enema, administered nightly

Interventions

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Clotrimazole

One retention enema, administered nightly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Web

OTHER

Sponsor Role lead

Responsible Party

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Web

Assistant Professor of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul A. Rufo, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and Harvard Medical School

Locations

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Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2202

Identifier Type: -

Identifier Source: org_study_id