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Home > "C" Clinical Trials Conditions > Clotrimazole Enemas for Pouchitis in Children and Adults  Clotrimazole Enemas for Pouchitis in Children and Adults
Clotrimazole Enemas for Pouchitis in Children and Adults
For Condition: Ulcerative Colitis,Inflammatory Bowel Disease,Ileitis,Pouchitis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
PaulRufo, Principal Investigator, Children's Hospital and Harvard Medical School
Children's Hospital *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Paul Rufo 617-355-6058
Additional Information:
Study ID Numbers: 2202;
Study Start Date: September 2002
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061282
Other Ulcerative Colitis Studies:
1. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
2. A pharmacokinetic study to determine the oral bioavailability of methotrexate in patients with inflammatory bowel disease
3. Immune Regulation in Ulcerative Colitis or Crohn's Disease
4. Humanized anti-IL-2 receptor monoclonal antibody in moderate-to-severe ulcerative colitis
5. Clotrimazole Enemas for Pouchitis in Children and Adults
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Clotrimazole Enemas for Pouchitis in Children and Adults
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