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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-UMIN000004201 |
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Date of registration:
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14/09/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis
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Scientific title:
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The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis - Hyogo College of Medicine, Osaka Medical College, Osaka City University Project 1, Tacrolimus-Ulcerative Colitis, 3 [Mucosal Healing for Prognosis] : HOOP1 (TCL-UC)-3 [MHP] |
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Date of first enrolment:
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2013/12/02 |
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Target sample size:
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50 |
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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=R000005048 |
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Study type:
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Interventional |
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Study design:
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Parallel 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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Kenji Watanabe |
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Address:
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1-4-3, Asahi-machi, Abeno-ku, Osaka
Japan |
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Telephone:
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0666453811 |
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Email:
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kenjiw@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University, Graduate School of Medicine Gastroenterology |
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Name:
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Kenji Watanabe |
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Address:
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1-4-3, Asahi-machi, Abeno-ku, Osaka
Japan |
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Telephone:
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0666453811 |
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Email:
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kenjiw@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University, Graduate School of Medicine Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)The treatment with immunomodulator or anti-TNF alpha agents within 12 weeks before administration of tacrolimus 2)The treatment with cytapheresis within 12 weeks before administration of tacrolimus 3)The patients who are not suitable for treatment of immunomodulator 4)The patients after colectomy 5)the patients with renal disorder
Age minimum:
16years-old
Age maximum:
65years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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The patients with moderate to severe active refractory ulcerative colitis
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Intervention(s)
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Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus,
Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus,
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Primary Outcome(s)
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Remission rate at 48 weeks after the administration of tacrolimus
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Source(s) of Monetary Support
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None
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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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