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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031839
Receipt No. R000035950
Scientific Title Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/23

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Basic information
Public title Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis
Acronym Safety and efficacy of Budesonide administration after EBD for CD patients
Scientific Title Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis
Scientific Title:Acronym Safety and efficacy of Budesonide administration after EBD for CD patients
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of administrating budesonide after EBD in CD patients with intestinal stenosis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safety within 12 weeks after EBD
Key secondary outcomes 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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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.
Key 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
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka Suita-city Osaka
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Shinzaki
Organization Osaka University Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Homepage URL
Email shinzaki@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Department of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor 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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Hospital Department of Medical Innovation
Address 2-2 Yamadaoka Suita-city Osaka
Tel 06-6210-8290
Email jim-chiken@hp-crc.med.osaka-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 02 Month 28 Day
Date of IRB
2018 Year 03 Month 30 Day
Anticipated trial start date
2018 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 22 Day
Last modified on
2020 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035950

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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