UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031703 |
|---|---|
| Receipt number | R000036207 |
| Scientific Title | Oral Beclometasone dipropionate for for gut GVHD |
| Date of disclosure of the study information | 2018/03/15 |
| Last modified on | 2018/09/24 18:43:09 |
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Basic information
Public title
Oral Beclometasone dipropionate for for gut GVHD
Acronym
BDP for gut GVHD
Scientific Title
Oral Beclometasone dipropionate for for gut GVHD
Scientific Title:Acronym
BDP for gut GVHD
Region
| Japan |
Condition
Condition
Gut Graft-versus-host disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety for gut GVHD to avoid the side effect of systemic steroid treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy for upper/lower digestive symptom at four
months after treatment by NIH GVHD response criteria
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
Historical
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
oral beclometasone treatment for four months
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
| 11 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male
Key inclusion criteria
a pediatric case with steroid dependent gut gVHD
Key exclusion criteria
no active cytomegalovirus (CMV) infection and no CMV antigenemia for confirmed endoscopically gut GVHD
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Hamada |
Organization
University of Ryukyus, hospital
Division name
Department of Pediatrics
Zip code
Address
207 Uehara, Nishihara, Okinawa
TEL
0988953331
shamada@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Hamada |
Organization
University of Ryukyus, hospital
Division name
Department of Pediatrics
Zip code
Address
207 Uehara, Nishihara, Okinawa
TEL
0988953331
Homepage URL
shamada@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Department of Pediatrics, University of Ryukyus, hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, University of Ryukyus, hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 03 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 15 | Day |
Last follow-up date
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 | 13 | Day |
Last modified on
| 2018 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036207
