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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-UMIN000002796 |
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Date of registration:
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25/11/2009 |
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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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Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial.
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Scientific title:
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Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. - Clinical trial of tacrolimus for patients with Crohn's disease |
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Date of first enrolment:
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2009/11/01 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002658 |
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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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Phase II
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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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Hiroshi Nakase |
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Address:
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54 Kawahara-cho, Shogoin, Sakyoku, Kyoto
Japan |
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Telephone:
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075-751-4319 |
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Email:
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hiropy_n@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Department of Gastroenterology and Hepatology |
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Name:
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Chiba Tsutomu |
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Address:
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54 Kawahara-cho, Shogoin, Sakyoku, Kyoto
Japan |
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Telephone:
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075-751-4319 |
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Email:
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chiba@kuhp.kyoto-u.ac.jp |
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Affiliation:
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Kyoto University Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: (1)patients with severe active disease-massive bleeding case, perforating case(2)patients with severe cardiac disease, liver disease, respiratory disease (3)patients with renal disease and hyperkalemia (4)patients with malignant disease, history of malignancy (5)patients with severe infection (6)patient having pregnancy or having the possiblity of pregnancy
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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Crohn's disease
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Intervention(s)
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We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks. For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml).
placebo control
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Primary Outcome(s)
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Crohn's disease activity index at 0.4.8 weeks after treatment
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Secondary Outcome(s)
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(1)change of CRP (2)percentage of patients achieved remission after treatment (3)safty (4)percentage of pateints with decreasing more than 100 points of CDAI after treatment
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Source(s) of Monetary Support
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the Ministry of Health, Labor, and Welfare, Japan
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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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Yes |
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Date Posted:
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Date Completed:
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31/12/2015 |
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URL:
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