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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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9 January 2023 |
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Main ID: |
NCT00061282 |
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Date of registration:
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23/05/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Clotrimazole Enemas for Pouchitis in Children and Adults
CAPTURE |
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Scientific title:
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Clotrimazole Enemas for Pouchitis in Children and Adults |
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Date of first enrolment:
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September 30, 2002 |
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Target sample size:
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11 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00061282 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Paul A. Rufo, MD, MMSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital and Harvard Medical School |
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Key inclusion & exclusion criteria
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- 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
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pouchitis
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Inflammatory Bowel Disease
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Ileitis
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Ulcerative Colitis
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Intervention(s)
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Drug: Clotrimazole
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Primary Outcome(s)
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Improvement in Pouchitis Disease Activity Index (PDAI)
[Time Frame: 30 Days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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