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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-UMIN000031839 |
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Date of registration:
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01/04/2018 |
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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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Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis
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Scientific title:
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Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients |
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Date of first enrolment:
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2018/04/01 |
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Target sample size:
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15 |
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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=R000035950 |
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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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Tetsuo
Takehara |
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Address:
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2-2 Yamadaoka Suita-city Osaka
Japan |
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Telephone:
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06-6879-3621 |
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Email:
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takehara@gh.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Name:
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Shinichiro
Shinzaki |
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Address:
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2-2 Yamadaoka, Suita, Osaka
565-0871
Japan |
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Telephone:
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06-6879-3621 |
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Email:
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shinzaki@gh.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients with more than 5 centimeters long stenosis Patients with internal or external fistula Patients with active infection, including abscess Patients with oral treatment of antithrombotic drugs or low platelet that counts less than 50000 per microlitter Patients with cancer Patients under 20 years old Patients with severy bad general condition Patients who are administered steroids within 4 weeks Patients who are judged inapropriate by doctors
Age minimum:
20years-old
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
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Intervention(s)
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At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.
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Primary Outcome(s)
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safety within 12 weeks after EBD
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Secondary Outcome(s)
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safety within 52 weeks after EBD rate of non-intestinal resection, non-reEBD and non-hospitalization rate of non-restenosis at 52 weeks after EBD
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Source(s) of Monetary Support
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Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
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Ethics review
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Status: YES
Approval date: 30/03/2018
Contact:
jim-chiken@hp-crc.med.osaka-u.ac.jp
Osaka University Hospital Department of Medical Innovation
06-6210-8290
jim-chiken@hp-crc.med.osaka-u.ac.jp
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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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31/03/2023 |
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URL:
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