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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033049
Receipt No. 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

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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
Email 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
Email yamaguchi@douai.jp

Sponsor
Institute Department of Pediatrics, Hachioji Hospital, Faculty of Medicine, Tokai University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037677

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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