UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033539 |
|---|---|
| Receipt number | R000038244 |
| Scientific Title | Examination of cognitive function and driving skill after alcohol intake Part2 |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2018/10/10 15:20:44 |
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Basic information
Public title
Examination of cognitive function and driving skill after alcohol intake Part2
Acronym
Examination of cognitive function and driving skill after alcohol intake Part2
Scientific Title
Examination of cognitive function and driving skill after alcohol intake Part2
Scientific Title:Acronym
Examination of cognitive function and driving skill after alcohol intake Part2
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeting Japanese, we observe how much the expiration alcohol level correlates with cognitive function testing and whether could be index of a cognitive function for safe driving.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The comparison of the score for DSST, TMT Pert A and B between before intake alcohol and after intake alcohol
2. The comparison of the score for evaluation for rehabilitation driving ability before intake alcohol and after intake alcohol
Key secondary outcomes
Examination of software cognitive function score before and after alcohol consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The group taken with Alcohol
Interventions/Control_2
The group do not taken with Alcohol
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The healthy person who is from 20 years old to 65 years old and can intake alcohol with an examination and agrees
2) The person who has a driver's license
3) The person who can come to the hospital using public transport or on foot on the study day
4) The person who understand enough the explanation about taking this examination and agrees on this study
Key exclusion criteria
1) The person who takes the medicine which influences on one's cognitive function such as an antihistamine, the sleep inducing drug
2) Woman who is pregnant or pregnant possibilities, a woman who is nursing
3) The person whom AUDIT score is over eight points.
4) The person who took perform Tokyo University-type ALDH2 and score less than 0 point.
5) The person smokes
6) The person who has liver dysfunction pointed out
7)The person who is seen as a inappropriate by a doctor who is in charge of the examination
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiho Sodenaga |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
m2sode@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Osada |
Organization
St. Marianna University School Of Medicine
Division name
Neuropsychiatry
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
k2osada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School Of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School Of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 07 | Month | 30 | 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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 25 | 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 | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038244
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
