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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-UMIN000011236 |
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Date of registration:
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20/07/2013 |
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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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Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission -
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Scientific title:
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Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - - Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation |
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Date of first enrolment:
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2011/05/02 |
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Target sample size:
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200 |
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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=R000013167 |
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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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Not selected
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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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Katsuyoshi Matsuoka |
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Address:
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35 Shinanomachi, Shinjuku Tokyo
Japan |
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Telephone:
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03-3353-122 |
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Email:
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matsuoka@z2.keio.jp |
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Affiliation:
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Keio University School of Medicine Gastroenterology and Hepatology |
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Name:
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Katsuyoshi Matsuoka |
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Address:
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35 Shinanomachi, Shinjuku Tokyo
Japan |
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Telephone:
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03-3353-1211 |
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Email:
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matsuoka@z2.keio.jp |
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Affiliation:
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Keio University School of Medicine Gastroenterlogy and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Past history of adverse effect to mesalazine.
Age minimum:
15years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Ulcerative colitis
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Intervention(s)
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Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding.
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Primary Outcome(s)
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Time to disappearance of rectal bleeding Rate of disappearance of rectal bleeding Rate of adverse events
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Source(s) of Monetary Support
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Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School 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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