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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011868
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email k-sienbu.mail@marianna-u.ac.jp

Sponsor
Institute St.Marianna university school of medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013577


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