UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033049 |
|---|---|
| Receipt number | R000037677 |
| Scientific Title | A randomized, double-blind, placebo-controlled cross-over study of epicutaneous immunotherapy for food allergy. |
| Date of disclosure of the study information | 2018/06/19 |
| Last modified on | 2018/06/19 14:12:19 |
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Basic information
Public title
A randomized, double-blind, placebo-controlled cross-over study of epicutaneous immunotherapy for food allergy.
Acronym
Epicutaneous immunotherapy for food allergy.
Scientific Title
A randomized, double-blind, placebo-controlled cross-over study of epicutaneous immunotherapy for food allergy.
Scientific Title:Acronym
Epicutaneous immunotherapy for food allergy.
Region
| Japan |
Condition
Condition
Food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We performed a randomized, double-blind placebo-controlled cross-over study to evaluate the efficacy of epicutaneous immunotherapy in the treatment of food allergy in children.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects of epicutaneous immunotherapy were evaluated according to the cumulative tolerated dose in an oral food challenge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food | Device,equipment |
Interventions/Control_1
egg allergy allergen phase
Interventions/Control_2
egg allergy placebo phase
Interventions/Control_3
milk allergy allergen phase
Interventions/Control_4
milk allergy placebo phase
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
children with food Allergy
Key exclusion criteria
children without food Allergy
Target sample size
13
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Yamaguchi |
Organization
Hachioji Hospital, Faculty of Medicine, Tokai University
Division name
Department of Pediatrics
Zip code
Address
1838 ishikawa machi, Hachioji, Tokyo, JAPAN, 192-0032
TEL
042-639-1111
yamaguchi@douai.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Yamaguchi |
Organization
Hachioji Hospital, Faculty of Medicine, Tokai University
Division name
Department of Pediatrics
Zip code
Address
1838 ishikawa machi, Hachioji, Tokyo, JAPAN, 192-0032
TEL
042-639-1111
Homepage URL
yamaguchi@douai.jp
Sponsor or person
Institute
Department of Pediatrics, Hachioji Hospital, Faculty of Medicine, Tokai University
Institute
Department
Personal name
Funding Source
Organization
Hachioji Hospital, Faculty of Medicine, Tokai University
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
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 | 06 | Month | 19 | 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
| 2011 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 28 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037677
