NCT00061282: CAPTURE

Clotrimazole Enemas for Pouchitis in Children and Adults

Terminated Phase 1, PHASE2 Last updated 9 December 2022

What this trial tests

Phase 1, PHASE2 trial testing Clotrimazole in Ulcerative Colitis in 11 participants. Terminated before completion.

Timeline

30 September 2002

Primary endpoint
1 December 2020

1 December 2020

Quick facts

Lead sponsor	Web
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	11
Start date	30 September 2002
Primary completion	1 December 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Clotrimazole (clotrimazole) — full drug profile →

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Pouchitis — all drugs for Pouchitis →
• Ileitis — all drugs for Ileitis →
• Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →

Sponsor

Web — full company profile →

Who can join

2 and older, any sex, with Ulcerative Colitis or Pouchitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbial-Based and Microbial-Targeted Therapies for Inflammatory Bowel Diseases.
   Oka A, Sartor RB. · · 2020 · cited 126× · PMID 32006212 · DOI 10.1007/s10620-020-06090-z
2. Inflammatory pouch disease: The spectrum of pouchitis.
   Zezos P, Saibil F. · · 2015 · cited 47× · PMID 26269664 · DOI 10.3748/wjg.v21.i29.8739