UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011868 |
|---|---|
| Receipt number | R000013577 |
| Scientific Title | New product for oral food challenge test in children ;the development and the utility |
| Date of disclosure of the study information | 2013/09/26 |
| Last modified on | 2018/05/17 11:55:57 |
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Basic information
Public title
New product for oral food challenge test in children ;the development and the utility
Acronym
New product for oral food challenge test in children ;the development and the utility
Scientific Title
New product for oral food challenge test in children ;the development and the utility
Scientific Title:Acronym
New product for oral food challenge test in children ;the development and the utility
Region
| Japan |
Condition
Condition
egg allergy,milk allergy,wheat allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to certify that the test using new product is equal the induced rate, the extent of causing an allergy symptom to the usual test and that the test using new product is more utility than the usual test.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate is that their age,sex,another allergic disease,antigen-specific IgE antibody titer are not difference in the test using new product grop and the usual test group.
To certify that the test using new product is equal the induced rate, the extent of causing an allergy symptom to the usual test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
The patient is that need to complete remove their target food.
High induction rate group,that is the induced rate is over 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012).
The test is an usual test.
Interventions/Control_2
The patient is that need to complete remove their target food.
High induction rate group,that is the induced rate is over 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012).
The test is an using new product.
Interventions/Control_3
The patient is that need to complete remove their target food.
Low induction rate group,that is the induced rate is under 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012).
The test is an usual test.
Interventions/Control_4
The patient is that need to complete remove their target food.
Low induction rate group,that is the induced rate is under 0.6(it's expected from probability curve in Japanese Pediatric Guideline for Food Allergy 2012).
The test is an using new product.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
There is indication of oral food challenge test(Refer to Japanese pediatiric guidline for oral challenge test in Food allergy 2009) and to obtain there consent from the attorney of the child.
Key exclusion criteria
1.The condition of being unstoppable anti-allergy drug,theophylline preparation,steroid drugs.
2.The charge of research judge in an improper the test.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Natsuki Yoshioka |
Organization
St.Marianna university school of medicine
Division name
pediatrics
Zip code
Address
2-16-1,Sugao miyamae-ku,Kawaski-city,Kanagawa-ken
TEL
044-977-8111
natsuki-desu@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsuki yoshioka |
Organization
St.Marianna university school of medicine
Division name
pediatrics
Zip code
Address
2-16-1,Sugao miyamae-ku,Kawaski-city,Kanagawa-ken
TEL
044-977-8111
Homepage URL
k-sienbu.mail@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and technology agency
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
AJINOMOTO
Name of secondary funder(s)
iwamotoseika,A-LIFE
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
聖マリアンナ医科大学病院（神奈川県）、川崎市立多摩病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 26 | 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
| 2013 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013577
| 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 |
