UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032753 |
|---|---|
| Receipt number | R000037355 |
| Scientific Title | Studies on Alterations in Brain Function after Alcohol Administration Using MRI |
| Date of disclosure of the study information | 2018/05/29 |
| Last modified on | 2022/04/19 11:51:13 |
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Basic information
Public title
Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Acronym
Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Scientific Title
Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Scientific Title:Acronym
Studies on Alterations in Brain Function after Alcohol Administration Using MRI
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study was to evaluate the effect of alcohol on the brain of healthy Japanese men and women aged 20 years or older and less than 30 years old, using MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI-measured data (T1, DTI, 1H-MRS, resting fMRI)
VAS score for subjective symptoms of drunkenness
Key secondary outcomes
Ethanol
Acetaldehyde
Acetic acid
Lactic acid
Pyruvic acid
Hematocrit
Plasma glucose
Plasma vasopressin
Plasma TGFBeta
Plasma amino acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Alcohol clamping method
Interventions/Control_2
Alcohol clamping method
Wash out
Controlled Trial
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age: 20 years or older, less than 30 years
2.Gender: Healthy Japanese men and women without disease
3.Right-handed person
4.Nonsmoker
5.Person who drink alcohol more frequently than once or twice a month.
6.Individuals with ALDH2 alcohol-susceptibility genes *1/*2
Key exclusion criteria
1.Patients with serious or past medical conditions of the heart, liver or kidney
2.Persons currently receiving continuous treatment with drugs
3.Persons with a history of drug or food allergy
4.Patients who are or have a history of treatment for drug dependence or abuse
5.Persons whose working hours are irregular, such as those who have worked at night
6.Subjects who are currently participating in another clinical study or have participated in another clinical study within the previous 3 months
7.Persons using cardiac pacemakers
8.Persons using vascular clips
9.Those using nerve electrical stimulators
10.Persons using implantable pumps
11.Persons in whom a piece of metal is in the body for some reason (including accidents and injuries)
12.Persons with tattoos (including one-point tattoos)
13.Persons with internal metal plates or screws for prostheses such as fractures
14.Other than the above, the investigator considered inappropriate for participation in the study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
ochitani@huma-rd.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Ochitani |
Organization
HUMA R&D CORP
Division name
Clinical Development Division
Zip code
108-0014
Address
Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL
81-3-3431-1260
Homepage URL
ochitani@huma-rd.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committees of Nihonbashi Egawa Clinic
Address
2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel
03-5204-0311
jim@medipharma.co.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
| 2018 | Year | 05 | Month | 29 | 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
18
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The supply of materials used for analysis and measurement was delayed.
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
| 2018 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 21 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 21 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037355
