UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036717 |
|---|---|
| Receipt number | R000041836 |
| Scientific Title | Measurement of plasma acetaldehyde by a new method for single intake of alcoholic beverages in healthy adults |
| Date of disclosure of the study information | 2019/05/13 |
| Last modified on | 2022/05/14 12:37:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Measurement of plasma acetaldehyde by a new method for single intake of alcoholic beverages in healthy adults
Acronym
Study on new measurement method of plasma acetaldehyde
Scientific Title
Measurement of plasma acetaldehyde by a new method for single intake of alcoholic beverages in healthy adults
Scientific Title:Acronym
Study on new measurement method of plasma acetaldehyde
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate measurements of plasma acetaldehyde concentrations
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate measurements of plasma acetaldehyde concentrations
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. BMI 18.5<= , <30.0 kg/m2
2. No abnormal findings in physical examination
3. Giving written informed conset
Key exclusion criteria
1. Having allergy for alcohol and/or intolerance for alcohol
2. Having any disease that needs to be treated
3. Having history of any severe allergy
4. Having history of any drug abuse and/or alcohol abuse
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Otani |
Organization
Oita University Faculty of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-town, Yufu-city, Oita
TEL
097-586-5952
naoyuki@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Otani |
Organization
Oita University Faculty of Medicine
Division name
Clinical Pharmacology and Therapeutics
Zip code
879-5593
Address
1-1 Idaigaoka, Hasama-town, Yufu-city, Oita
TEL
097-586-5952
Homepage URL
naoyuki@oita-u.ac.jp
Sponsor or person
Institute
Oita Unversity Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Clinical Pharmacology and Therapeutics, Faculty of Medicine, Oita University
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
Oita University Faculty of Medicine Ethics Committee
Address
1-1 Hasama-machi, Yufu-City Oita
Tel
097-586-5120
syomu@oita-u.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 | 05 | Month | 13 | 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
| 2019 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Take 500 ml beer for 30min.
2. Collecting blood, breath, and saliva 3 times each when before taking beer, after one hour and after four hours.
Management information
Registered date
| 2019 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041836
