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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026982
Receipt No. R000024510
Scientific Title Study of skin prick test using with histamine as positive control
Date of disclosure of the study information 2017/04/13
Last modified on 2018/08/12

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Basic information
Public title Study of skin prick test using with histamine as positive control
Acronym Histamine and skin prick test
Scientific Title Study of skin prick test using with histamine as positive control
Scientific Title:Acronym Histamine and skin prick test
Region
Japan

Condition
Condition Allergic diseases including bronchial asthma, food allergy, atopic dermatitis and allergic thinitis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of accuracy of diagnosis of allergens with and without histamine as positive control
Basic objectives2 Others
Basic objectives -Others Validation of strength of positive response to histamine
Investigation into frequency of hyper-sensitivity and hypo-sensitivity to histamine
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Positive skin prick test(SPT)
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Physician-suspected patients with IgE-mediated allergic reactions, such as bronchial asthma, allergic rhinitis, allergic conjunctivitis, food allergy, anaphylaxis, urticaria, drug allergy and latex allergy etc.
Key exclusion criteria Patients without the intact skin to perform SPT
Patients with the skin untreated with steroid ointment to perform SPT
Patients with steroid IV in one month
Patients with immunosuppressive drug treatment in one month
Patients with antiallergic drug po in one week
Patients with antihistamine po in one week
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miwa Shinoahra
Organization Ehime University Hospital
Division name Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City, Ehime
TEL 089-960-5320
Email shinohara.miwa.vv@ehime-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miwa Shinoahra
Organization Ehime University Hospital
Division name Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City, Ehime
TEL 089-960-5320
Homepage URL
Email shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute Ehime University Hospital
Institute
Department

Funding Source
Organization Ehime University Hospital
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
2017 Year 04 Month 13 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Skin prick tests using with bifurcated needles.

Management information
Registered date
2017 Year 04 Month 13 Day
Last modified on
2018 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024510

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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