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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036717
Receipt No. 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 2019/05/12

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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
Email 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
Email naoyuki@oita-u.ac.jp

Sponsor
Institute Oita Unversity Faculty of Medicine
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 27 Day
Date of IRB
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
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041836

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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