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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032227
Receipt No. R000036751
Scientific Title Clinical trial for Yamakagashi and Redback spider bites
Date of disclosure of the study information 2018/04/15
Last modified on 2018/04/13

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Basic information
Public title Clinical trial for Yamakagashi and Redback spider bites
Acronym Clinical trial for Yamakagashi and Redback spider bites
Scientific Title Clinical trial for Yamakagashi and Redback spider bites
Scientific Title:Acronym Clinical trial for Yamakagashi and Redback spider bites
Region
Japan

Condition
Condition Yamakagashi and Redback spider bites
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of antivenom for Yamakagashi and Redback spider bites
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Survival rate
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Yamakagashi and redback spider antivenom
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 who required antivenom
Key exclusion criteria Informend consent was not obtained
Inappropriate for the study
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Hifumi
Organization St.Luke International Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 9-1, Akashicho, Chuouku, Tokyo, 104-8560, Japan
TEL 03-3541-5151
Email hitoru@luke.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Hifumi
Organization St.Luke International Hospital
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 9-1, Akashicho, Chuouku, Tokyo, 104-8560, Japan
TEL 03-3541-5151
Homepage URL
Email hitoru@luke.ac.jp

Sponsor
Institute St.Luke International Hospital
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 15 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
2018 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 20 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
2018 Year 04 Month 13 Day
Last modified on
2018 Year 04 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036751

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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