World Health Organization site
Skip Navigation Links

Main
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-UMIN000031839
Date of registration: 01/04/2018
Prospective Registration: Yes
Primary sponsor: Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Public title: Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis
Scientific title: 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
Date of first enrolment: 2018/04/01
Target sample size: 15
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035950
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Tetsuo    Takehara
Address:  2-2 Yamadaoka Suita-city Osaka Japan
Telephone: 06-6879-3621
Email: takehara@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Name: Shinichiro    Shinzaki
Address:  2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Telephone: 06-6879-3621
Email: shinzaki@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Crohn's disease
Intervention(s)
At the time of resumption of food, patients recerve 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)
Source(s) of Monetary Support
Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Secondary Sponsor(s)
Japan Community Health care Organizationi Osaka Hospital, Gastroenterology and Hepatology National Hospital Organization Osaka National Hospital, Gastroenterology and Hepatology Osaka Rosai Hospital , Gastroenterology and Hepatology Kansai Rosai Hospital, Gastroenterology and Hepatology Itami City Hospital, Gastroenterology and Hepatology Hyogo Prefectural Nishinomiya Hospital, Gastroenterology and Hepatology Nishinomiya Municipal central hospital, Gastroenterology and Hepatology
Ethics review
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
Results
Results available:
Date Posted:
Date Completed: 31/12/2021
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history