UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026982 |
|---|---|
| Receipt number | 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 11:19:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
shinohara.miwa.vv@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024510
