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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.
Register: JPRN
Last refreshed on: 20 April 2020
Main ID:  JPRN-jRCT1051190043
Date of registration: 02/09/2019
Prospective Registration: No
Primary sponsor: Takehara Tetsuo
Public title: Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis
Scientific title: Safety and efficacy of Budesonide administration after endoscopic balloon dilation for Crohn's disease patients with intestinal stenosis - OGF1707
Date of first enrolment: 20/12/2018
Target sample size: 15
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCT1051190043
Study type:  Interventional
Study design:  single arm study, open(masking not used), uncontrolled control, single assignment, treatment purpose  
Phase:  2
Countries of recruitment
Japan
Contacts
Name: Shinichiro    Shinzaki
Address:  2-15, Yamadaoka, Suita, Osaka, Japan 565-0871 Osaka Japan
Telephone: +81-6-6879-3621
Email: shinzaki@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Hospital
Name: Tetsuo    Takehara
Address:  2-15, Yamadaoka, Suita, Osaka, Japan 565-0871 Osaka Japan
Telephone: +81-6-6879-3621
Email: takehara@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Hospital
Key inclusion & exclusion criteria
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: 20age
Age maximum: Not applicable
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
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.
Primary Outcome(s)
Safety within 12 weeks after EBD
Secondary Outcome(s)
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
Secondary ID(s)
UMIN000031839
Source(s) of Monetary Support
Secondary Sponsor(s)
Iijima Hideki
Ethics review
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
Results
Results available:
Date Posted:
Date Completed:
URL:
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