Clotrimazole Enemas for Pouchitis in Children and Adults

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by FDA Office of Orphan Products Development.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:
NCT00061282
First received: May 23, 2003
Last updated: September 19, 2007
Last verified: September 2005
  Purpose

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 Intervention Phase
Ulcerative Colitis
Pouchitis
Ileitis
Inflammatory Bowel Disease
Drug: Clotrimazole
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Clotrimazole Enemas for Pouchitis in Children and Adults

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

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

Estimated Enrollment: 40
Study Start Date: September 2002
Estimated Study Completion Date: June 2008
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061282

Contacts
Contact: Paul A. Rufo, MD, MMSc 617-355-6058 paul.rufo@tch.harvard.edu
Contact: Tracee Cook, MS, PNP 617-355-6058 tracee.cook@tch.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Paul A. Rufo, MD, MMSc    617-355-6058    paul.rufo@tch.harvard.edu   
Contact: Thomas R. Walker, MD    617-355-6256    thomas.walker@tch.harvard.edu   
Principal Investigator: Paul A. Rufo, MD, MMSc         
Sub-Investigator: Thomas R. Walker, M.D.         
Sub-Investigator: Alan Leichtner, M.D.         
Sponsors and Collaborators
Investigators
Principal Investigator: Paul A. Rufo, MD, MMSc Children's Hospital and Harvard Medical School
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00061282     History of Changes
Other Study ID Numbers: 2202
Study First Received: May 23, 2003
Last Updated: September 19, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:
Pouchitis
Colitis
Ileitis

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ileitis
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Pouchitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Enteritis
Ileal Diseases
Pathologic Processes
Clotrimazole
Miconazole
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on July 23, 2014