UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026980 |
|---|---|
| Receipt number | 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 11:20:54 |
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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
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
shinohara.miwa.vv@ehime-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Ehime University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028563
