UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reaction
Title of the study (Brief title)	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	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
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	Miwa Shinohara
Organization	Ehime University Hospital
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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