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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027026
Receipt No. R000030985
Scientific Title Oral beclomethasone dipropionate treatment for gastrointestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2017/04/17
Last modified on 2019/04/24

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Basic information
Public title Oral beclomethasone dipropionate treatment for gastrointestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Acronym Oral beclomethasone dipropionate treatment for gastrointestinal GVHD after allo-HSCT
Scientific Title Oral beclomethasone dipropionate treatment for gastrointestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Oral beclomethasone dipropionate treatment for gastrointestinal GVHD after allo-HSCT
Region
Japan

Condition
Condition Patients with symptoms of acute gastrointestinal GVHD after allo-HSCT
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Treatment for gastrointestinal GVHD after allo-HSCT
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether beclomethasone improve GI GVHD grade or reduce the need for systemic glucocorticoid treatment, at two weeks after administration.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of oral beclomethasone
1-2capx4 /day; 4-8mg/day
about 50 days
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 Who are admitted to our hospital for the purpose of allogeneic hematopoietic stem cell transplantation , and cases in which data can be collected for research.
Key exclusion criteria 1. Cases who can not be collected data.
2. Patients whose research managers judged inappropriate as subjects.
3. Patients who had requested refusal to investigate.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Junji
Middle name
Last name Tanaka
Organization Tokyo Women's Medical University
Division name Department of Hematology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Email jutanaka@twmu.ac.jp

Public contact
Name of contact person
1st name Norina
Middle name
Last name Tanaka
Organization Tokyo Women's Medical University
Division name Department of Hematology
Zip code 162-8666
Address 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-8111
Homepage URL
Email tanaka.norina@twmu.ac.jp

Sponsor
Institute Tokyo Women's Medical University, Department of Hematology
Institute
Department

Funding Source
Organization Tokyo Women's Medical University, Department of Hematology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Women's Medical University, IRB
Address 8-1, Kawada-cho, Shinjyuku-ku, Tokyo, Japan
Tel 03-3353-8111
Email krinri.bm@twmu.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
2017 Year 04 Month 17 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 Completed
Date of protocol fixation
2016 Year 11 Month 22 Day
Date of IRB
2016 Year 11 Month 22 Day
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
2019 Year 01 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 17 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030985

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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