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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-UMIN000005762 |
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Date of registration:
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13/06/2011 |
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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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The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease
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Scientific title:
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The Study for Efficacy of Adalimumab Conbined Elemental Diet Therapy for Crohn's Disease - The Efficacy of Adalimumab |
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Date of first enrolment:
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2010/10/27 |
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Target sample size:
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40 |
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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=R000006812 |
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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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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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Email:
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Affiliation:
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Osaka City University Gradatescool of Medicine Gastroenterology |
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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nkamata@med.osaka-cu.ac.jp |
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Affiliation:
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Osaka City University Gradatescool of Medicine Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)The patient who has internal fistula 2)The patient who is planning to have an operation 3)The patient who is short bowel syndorome 4)The patient of contraindication for adalimumab or Elental 5)The case which is hard to get the patient's consent 6)The patient who was judged for unsuitable by responsibility doctor
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Crohn's Disease patient who was ineffective for present therapy and who has not been treated with anti TNF alpha antibody.
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Intervention(s)
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1)Adalimumab (HUMIRA 40mg for SC Injection) Inject SC 160mg on Day 1, then inject SC 80 mg on Day 15, and inject SC 40 mg every other week, beginning on Day 29. 2)Elental(1 kcal/ml; 80g/300ml)
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Primary Outcome(s)
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CDAI score in the 28th week (the rate of remission, CR70, CR100), SF-36, IBDQ
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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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