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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-jRCT1051190043 |
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Date of registration:
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02/09/2019 |
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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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Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis
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Scientific title:
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Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707 |
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Date of first enrolment:
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20/12/2018 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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https://jrct.niph.go.jp/latest-detail/jRCT1051190043 |
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Study type:
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Interventional |
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Study design:
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single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose
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Phase:
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2
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Contacts
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Name:
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Shinichiro
Shinzaki |
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Address:
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2-15, Yamadaoka, Suita, Osaka, Japan
565-0871
Osaka
Japan |
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Telephone:
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+81-6-6879-3621 |
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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 Hospital |
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Name:
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Tetsuo
Takehara |
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Address:
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2-15, Yamadaoka, Suita, Osaka, Japan
565-0871
Osaka
Japan |
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Telephone:
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+81-6-6879-3621 |
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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 Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: Mild to moderate active Crohn's disease patients with written consent at Osaka University Hospital and affiliated hospitals, who have intestinal stenosis and are scheduled or recieved endoscopic balloon dilation (EBD), are included.
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:
Not applicable
Age maximum:
Not applicable
Gender:
Both
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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 after endoscopic balloon dilation, patients receive 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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Secondary ID(s)
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UMIN000031839
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Source(s) of Monetary Support
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Ethics review
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Status: Approval
Approval date: 10/04/2019
Contact:
handai-nintei@hp-crc.med.osaka-u.ac.jp
Osaka University Clinical Research Review Committee
+81-6-6210-8324
handai-nintei@hp-crc.med.osaka-u.ac.jp
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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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