Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061282
Status:
TERMINATED
Last Update Posted:
2022-12-09
First Post:
2003-05-23
Brief Title:
Clotrimazole Enemas for Pouchitis in Children and Adults
Sponsor:
Web
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Clotrimazole Enemas for Pouchitis in Children and Adults
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Horizon
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPTURE
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 mgday 8 subjects or 4000mgday 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 mgday clotrimazole 8 subjects or 7500mgday 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
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 mgday 8 subjects or 4000mgday 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 mgday clotrimazole 8 subjects or 7500mgday 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None