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Clotrimazole Enemas for Pouchitis in Children and Adults (CAPTURE)

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ClinicalTrials.gov Identifier: NCT00061282
Recruitment Status : Suspended (Funding Horizon)
First Posted : May 26, 2003
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Pouchitis Ileitis Inflammatory Bowel Disease Drug: Clotrimazole Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Clotrimazole Enemas for Pouchitis in Children and Adults
Study Start Date : September 2002
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Clotrimazole
One retention enema, administered nightly
Active Comparator: 2
Clotrimazole Therapy
Drug: Clotrimazole
One retention enema, administered nightly
Active Comparator: 3
Clotrimazole Therapy
Drug: Clotrimazole
One retention enema, administered nightly


Outcome Measures

Primary Outcome Measures :
  1. Improvement in Pouchitis Disease Activity Index (PDAI) [ Time Frame: 30 Days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061282


Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Paul Rufo
Investigators
Principal Investigator: Paul A. Rufo, MD, MMSc Children's Hospital and Harvard Medical School
More Information

Additional Information:
Responsible Party: Paul Rufo, Assistant Professor of Pediatrics, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00061282     History of Changes
Other Study ID Numbers: 2202
First Posted: May 26, 2003    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Paul Rufo, Boston Children's Hospital:
Pouchitis
Colitis
Ileitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Inflammatory Bowel Diseases
Pouchitis
Ileitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Enteritis
Ileal Diseases