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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012898
Receipt No. R000015069
Scientific Title Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Date of disclosure of the study information 2014/01/19
Last modified on 2014/08/19

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Basic information
Public title Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Acronym Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Scientific Title Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Scientific Title:Acronym Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to establish the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas and the method for decreasing the remaining alcohol.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Breath and blood alcohol concentration
Key secondary outcomes Subjective symptom

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 The single intravenous injection of 14.6mL/m2 of ethanol
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult
Those who do not have a problem in alcohol-metabolizing enzyme activity at an alcoholic patch test
Key exclusion criteria Those who experience a remarkable face flush or poor health after about 100 ml of beer drinking
Those to whom the skin becomes red by ethanol disinfection
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nao Odagiri
Organization Hirosaki University School of Medicine and Hospital
Division name Pharmaceutical department
Zip code
Address 53 Hon-cho, Hirosaki, Aomori
TEL 0172-33-5111
Email odagiri-hki@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nao Odagiri
Organization Hirosaki University School of Medicine and Hospital
Division name Pharmaceutical department
Zip code
Address 53 Hon-cho, Hirosaki, Aomori
TEL 0172-33-5111
Homepage URL
Email odagiri-hki@umin.ac.jp

Sponsor
Institute Pharmaceutical department, Hirosaki University School of Medicine and Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 弘前大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 19 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 20 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 10 Month 31 Day
Date trial data considered complete
2014 Year 10 Month 31 Day
Date analysis concluded
2014 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 19 Day
Last modified on
2014 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015069

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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