UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027026 |
|---|---|
| Receipt number | 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 20:00:26 |
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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
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
tanaka.norina@twmu.ac.jp
Sponsor or person
Institute
Tokyo Women's Medical University, Department of Hematology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030985
