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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035031
Receipt No. R000039942
Scientific Title Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan
Date of disclosure of the study information 2018/11/27
Last modified on 2018/11/27

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Basic information
Public title Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan
Acronym Risk of SJS/TEN Associated with Anticonvulsants in Japan
Scientific Title Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Associated with Anticonvulsants in Japan
Scientific Title:Acronym Risk of SJS/TEN Associated with Anticonvulsants in Japan
Region
Japan

Condition
Condition Stevens-Johnson syndrome (SJS)
Toxic epidermal necrolysis (TEN)
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to assess the risk of SJS/TEN in new users of anticonvulsants.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Cohort study: Cumulative incidence of SJS/TEN
Matched case-control study: Odds ratio for SJS/TEN
Key secondary outcomes

Base
Study type Observational

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 Cohort study:
Patients who meet the following criteria will be eligible for inclusion in this study:
1. Patients who were newly prescribed an anticonvulsant between April 1, 2012 to December 31, 2017
2. Patients who had an observational period of >90 days after initially being prescribed an anticonvulsant

Matched case-control study:
Patients who are identified by an algorithm and patients who are selected by risk-set sampling
Key exclusion criteria Cohort study:
None

Matched case-control study:
Patients who did not have an observational period of >180 days prior to the index date
Target sample size 5400000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Urushihara
Organization Keio University
Division name Division of Drug Development and Regulatory Science, Faculty of Pharmacy
Zip code
Address 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512 Japan
TEL 03-5400-2649
Email urushihara-hs@pha.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Urushihara
Organization Keio University
Division name Division of Drug Development and Regulatory Science, Faculty of Pharmacy
Zip code
Address 1-5-30 Shibakoen, Minato-ku, Tokyo 105-8512 Japan
TEL 03-5400-2649
Homepage URL
Email urushihara-hs@pha.keio.ac.jp

Sponsor
Institute Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 Keio University

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 27 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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Cohort study, Matched case-control study
Subjects: Patients who were registered in the Japan Medical Data Center (JMDC) Claims Database (April 1, 2012 through December 31, 2017) and satisfied the inclusion criteria

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2018 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039942

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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