UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032227 |
|---|---|
| Receipt number | R000036751 |
| Scientific Title | Clinical trial for Yamakagashi and Redback spider bites |
| Date of disclosure of the study information | 2018/04/15 |
| Last modified on | 2020/04/14 09:47:21 |
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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 | Toru |
| Middle name | |
| Last name | Hifumi |
Organization
St.Luke International Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
104-8560
Address
9-1, Akashicho, Chuouku, Tokyo, 104-8560, Japan
TEL
03-3541-5151
hitoru@luke.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Hifumi |
Organization
St.Luke International Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
104-8560
Address
9-1, Akashicho, Chuouku, Tokyo, 104-8560, Japan
TEL
03-3541-5151
Homepage URL
hitoru@luke.ac.jp
Sponsor or person
Institute
St.Luke International Hospital
Institute
Department
Personal name
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
St. Luke's International Hospital
Address
Chuouku akashichou9-1
Tel
03-3541-5151
hifumitoru@gmail.com
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
| 2018 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036751
