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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026980
Receipt No. R000028563
Scientific Title Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reaction
Date of disclosure of the study information 2017/04/13
Last modified on 2018/08/12

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Basic information
Public title Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reaction
Acronym Drug hypersensitivity study using a diagnosis algorithm to examinations
Scientific Title Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reaction
Scientific Title:Acronym Drug hypersensitivity study using a diagnosis algorithm to examinations
Region
Japan

Condition
Condition In this study, we investigate drug hypersensitivity using a definitive diagnosis algorithm (modified Mirakian R. Clin Exp Allergy. 2009 Jan;39:43-61.) to examinations of a suspected adverse drug reaction.
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determination of drugs causing adverse drug reactions
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Our definitive diagnosis algorithm has 4 steps. Primary endpoints are 1) skin prick test is positive in Step 2, 2) provocation test is positive in Step 3, and 3) significant associations between HLA types and kind of drug that has positive reaction by provocation test in Step 2.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Blood test, skin prick test and provocation test.
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 Individuals with diagnosed and suspected drug hypersensitivity in Ehime University Hospital.
Key exclusion criteria * Objectives without written informed concern.
* Objectives judged as ineligible by the chief of the study.
* Objectives with and suspected fetal and severe systemic drug reactions.
* Objectives without healthy skin region to be performed skin tests.
* Objectives without the skin region untreated by steroid ointments to be performed skin tests.
* Objectives with intravenous steroid within 1 month.
* Objectives with intravenous immunosuppressive agent within 1 month.
* Objectives with oral antiallergic drug within 1 week.
* Objectives with oral antihistamine within 1 week.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Miwa Shinohara
Organization Ehime University Hospital
Division name Department of Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
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 Shinohara
Organization Ehime University Hospital
Division name Department of Pediatrics
Zip code
Address 454 Shitsukawa, Toon-City Ehime, 791-0295, JAPAN
TEL 089-960-5320
Homepage URL
Email shinohara.miwa.vv@ehime-u.ac.jp

Sponsor
Institute Department of Pediatrics, Ehime University Hospital
Institute
Department

Funding Source
Organization Department of Pediatrics, Ehime University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Department of Pediatrics, Ehime University Hospital

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 愛媛大学医学部附属病院 (愛媛県)

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 04 Month 25 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

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=R000028563

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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