UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018142 |
|---|---|
| Receipt number | R000021007 |
| Scientific Title | low dose slow specific oral immunotherapy of hen's egg |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2023/11/30 19:18:18 |
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Basic information
Public title
low dose slow specific oral immunotherapy of hen's egg
Acronym
low dose slow specific oral immunotherapy of hen's egg
Scientific Title
low dose slow specific oral immunotherapy of hen's egg
Scientific Title:Acronym
low dose slow specific oral immunotherapy of hen's egg
Region
| Japan |
Condition
Condition
egg allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
effectiveness of the low dose egg specific oral immunotherapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
threshold level of egg white challenge test after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
low dose and high dose slow specifc oral immunotherapy
Interventions/Control_2
high dose slow specifc oral immunotherapy
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
egg allergy
Key exclusion criteria
severe egg allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yuri takaoka |
Organization
osaka prefectural hospital oraganization osaka prefectural medical center
Division name
pediatrics
Zip code
Address
3-7-1habikino habikino city osaka
TEL
0729572121
takaokayu@ra.opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | yuri takaoka |
Organization
osaka prefectural hospital oraganization osaka prefectural medical center
Division name
pediatrics
Zip code
Address
3-7-1habikino habikino city osaka
TEL
0729572121
Homepage URL
takaokayu@ra.opho.jp
Sponsor or person
Institute
osaka prefectural hospital oraganization osaka prefectural medical center
Institute
Department
Personal name
Funding Source
Organization
osaka prefectural hospital oraganization osaka prefectural medical center
Organization
Division
Category of Funding Organization
Local Government
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
| 2015 | Year | 07 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021007
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
