UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038579 |
|---|---|
| Receipt number | R000043962 |
| Scientific Title | Reliability and validity study of placebo thumbtack needle |
| Date of disclosure of the study information | 2019/11/15 |
| Last modified on | 2019/11/14 11:46:08 |
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Basic information
Public title
Reliability and validity study of placebo thumbtack needle
Acronym
Reliability and validity study of placebo thumbtack needle
Scientific Title
Reliability and validity study of placebo thumbtack needle
Scientific Title:Acronym
Reliability and validity study of placebo thumbtack needle
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of reliability and validity of placebo thumbtack needle
Basic objectives2
Others
Basic objectives -Others
Reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination of intervention type
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
thumbtack needle
Interventions/Control_2
Placebo thumbtack needle
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Subjects who can communicate in japanese
2.Subjects who are not suffering from an imunne disorder
3.Subjets who have a tendency to bleed
Key exclusion criteria
Subjects who do not meen inclusion criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Kimura |
Organization
Tokyo Ariake University of Medical and Health sciences
Division name
Graduate school of Health Sciences
Zip code
135-0063
Address
2-9-1 Ariake,Koto-ku,Tokyo
TEL
03-6703-7018
kimura@tau.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Tachikawa |
Organization
Tokyo Ariake University of Medical and Health sciences
Division name
Graduate school of Health Sciences
Zip code
135-0063
Address
2-9-1 Ariake,Koto-ku,Tokyo
TEL
03-6703-7000
Homepage URL
5218001@tau.ac.jp
Sponsor or person
Institute
Tokyo Ariake University of Medical and Health sciences
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical and Health sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Ariake University of Medical and Health Sciences
Address
2-9-1 Ariake Koto-ku, Tokyo 135-0063 Japan
Tel
+08-3-6703-7000
kida@tau.ac.jp
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
| 2019 | Year | 11 | 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
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 11 | Month | 14 | Day |
Last modified on
| 2019 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043962
