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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028037
Receipt No. R000032024
Scientific Title Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/01

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Basic information
Public title Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
Acronym MOSST Study
Scientific Title Multicenter Open-trial of Steroid pulse therapy for SJS/TEN
Scientific Title:Acronym MOSST Study
Region
Japan Asia(except Japan) Europe

Condition
Condition SJS/TEN
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of multicenter open-trial of Steroid pulse therapy for SJS/TEN in acute stage
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Scoring clinical evaluations; skin involvement, lip/oral mucosa involvement, eye involvement, general findings
Key secondary outcomes Vital sign

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Initiation of steroid pulse therapy within 3 days from onset
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
20 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.Cases with definite diagnosis of SJS/TEN
2.Blister or epidermolysis area with more
than 1% of body surface area
3.New formation of blister or erythema
4.Obtaining informed consent
5.Within 3 days from onset
Key exclusion criteria 1.Medication of Immunosuppressive or
Immunomodulatory drugs for more than 3 days within 7days from onset or Immunosuppressive such as plasmapheresis
2.History of allergy to preservative products in adrenal cortical steroid
4.Affected severe sepsis
5.Affected severe cardiac disease
6.Active gastric ulceror bleeding
7.Uncontrolled DM
8.History of leg gangrene
9.active virus disease
10.Hepatitis B virus carrier
11.Untreated tuberculosis
12.Hemodialysis
13.Complicating drug-induced hypersensitivity syndrome
14.Decision by primary doctor
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eishin Morita
Organization Faculty of Medicine SHIMANE University
Division name Dermatology
Zip code
Address 89-1 Enya-cho, Izumo, 693-8501, Shimane, Japan
TEL 0853-20-2210
Email emorita@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Niihara
Organization Faculty of Medicine SHIMANE University
Division name Dermatology
Zip code
Address 89-1 Enya-cho, Izumo, 693-8501, Shimane, Japan
TEL 0853-20-2210
Homepage URL
Email ofcourse@med.shimane-u.ac.jp

Sponsor
Institute Faculty of Medicine SHIMANE University
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants (Research on Intractable Diseases) from the Ministry of Health, Labour and Welfare of Japan.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization 0

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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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
2017 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 06 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 07 Month 01 Day
Last modified on
2017 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032024

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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