UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009710 |
|---|---|
| Receipt number | R000011384 |
| Scientific Title | Long-term prognosis of severe cutaneous adverse drug reaction |
| Date of disclosure of the study information | 2013/01/07 |
| Last modified on | 2014/03/30 01:25:43 |
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Basic information
Public title
Long-term prognosis of severe cutaneous adverse drug reaction
Acronym
Long-term prognosis of severe cutaneous adverse drug reaction
Scientific Title
Long-term prognosis of severe cutaneous adverse drug reaction
Scientific Title:Acronym
Long-term prognosis of severe cutaneous adverse drug reaction
Region
| Japan |
Condition
Condition
Stevens-Johnson syndrome
Toxic epidermal necrolysis
Drug-induced hypersensitivity syndrome
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of residual and long-term prognosis in patients with severe cutaneous adverse drug reaction
Basic objectives2
Others
Basic objectives -Others
Investigation of residual and long-term prognosis in patients with severe cutaneous adverse drug reaction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long term prognosis by interview form
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
Patients with Stevens-Johnson syndrome, toxic epidermal necrolysis or drug-induced hypersensitivity syndrome
Key exclusion criteria
Patients regarded as inadequate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Aihara |
Organization
Yokohama City University Graduate School of Medicine
Division name
Environmental Immuno-Dermatology
Zip code
Address
Fukuura 3-9, Kanazawa, Yokohama
TEL
045-787-2675
nabetomo0968@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Watanabe |
Organization
Yokohama City University Graduate School of Medicine
Division name
Environmental Immuno-Dermatology
Zip code
Address
Fukuura 3-9, Kanazawa, Yokohama
TEL
045-787-2675
Homepage URL
nabetomo0968@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 01 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Results will be investigated based on medical chart and interview form
Management information
Registered date
| 2013 | Year | 01 | Month | 06 | Day |
Last modified on
| 2014 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011384
