UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012898 |
|---|---|
| Receipt number | 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 22:09:15 |
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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
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
odagiri-hki@umin.ac.jp
Sponsor or person
Institute
Pharmaceutical department, Hirosaki University School of Medicine and Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015069
