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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000013370 |
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Date of registration:
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07/03/2014 |
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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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Efficacy of infliximab therapy for refractory pouchitis
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Scientific title:
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Efficacy of infliximab therapy for refractory pouchitis - Infliximab therapy for refractory pouchitis |
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Date of first enrolment:
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2013/06/07 |
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Target sample size:
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10 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012736 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase I
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Countries of recruitment
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Japan
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Contacts
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Name:
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Motoi Uchino |
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Address:
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1-1Mukogawacho Nishinomiya Hyogo Japan
Japan |
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Telephone:
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0798-45-6371 |
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Email:
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uchino2s@hyo-med.ac.jp |
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Affiliation:
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Hyogo college of medicine Inflammatory bowel disease center |
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Name:
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Motoi Uchino |
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Address:
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1-1 mukogawacho Nishinomiya Hyogo Japan
Japan |
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Telephone:
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0798-45-6111 |
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Email:
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uchino2s@hyo-med.ac.jp |
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Affiliation:
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Hyogo college of medicine Inflammatory bowel disease center |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients with pre-existed malignancy, other infectious disease, heart failure, or infusion reaction for infliximab
Age minimum:
18years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ulcerative colitis, pouchitis
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Intervention(s)
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infliximab
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Primary Outcome(s)
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Efficacy of infliximab treatment will be assessed with pouchitis disease activity index before and after treatment
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Secondary Outcome(s)
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Evaluate the association between dose of anti-TNF alpha before treatment and efficacy of treatment
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Source(s) of Monetary Support
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Hyogo college of medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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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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