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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032753
Receipt No. 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 2019/05/14

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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
Email 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
Email ochitani@huma-rd.co.jp

Sponsor
Institute HUMA R&D CORP
Institute
Department

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
Email 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
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 Open public recruiting
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
2019 Year 12 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 05 Month 29 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037355

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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