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

May 23, 2003
September 19, 2007
September 2002
Not Provided
Improvement in Pouchitis Disease Activity Index (PDAI) [ Time Frame: 30 Days ]
Not Provided
Complete list of historical versions of study NCT00061282 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Clotrimazole Enemas for Pouchitis in Children and Adults
Clotrimazole Enemas for Pouchitis in Children and Adults

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Ulcerative Colitis
  • Pouchitis
  • Ileitis
  • Inflammatory Bowel Disease
Drug: Clotrimazole
One retention enema, administered nightly
  • Placebo Comparator: 1
    Intervention: Drug: Clotrimazole
  • Active Comparator: 2
    Clotrimazole Therapy
    Intervention: Drug: Clotrimazole
  • Active Comparator: 3
    Clotrimazole Therapy
    Intervention: Drug: Clotrimazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
June 2008
Not Provided
  • 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
Both
2 Years and older
Yes
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
United States
 
NCT00061282
2202
Yes
Not Provided
FDA Office of Orphan Products Development
Not Provided
Principal Investigator: Paul A. Rufo, MD, MMSc Children's Hospital and Harvard Medical School
FDA Office of Orphan Products Development
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP