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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000034443
Receipt No. R000039277
Scientific Title Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Date of disclosure of the study information 2018/10/11
Last modified on 2019/04/12

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Basic information
Public title Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Acronym Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Scientific Title Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Scientific Title:Acronym Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference of gastric transit time after ingestion of alcoholic drink and glucose solution.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The cross-sectional surface area of
the gastric antrum measured by ultrasound.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 30ml of whisky and 120ml of water.
Interventions/Control_2 The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 150ml of 11.2% glucose solution.
Interventions/Control_3 The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 150ml of water.
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
Key inclusion criteria Persons who fills everything the following
1) a person of 20years or more
2) a person who gives written informed
consent
Key exclusion criteria 1. a person who have gastrointestinal lesion.
2. a person who are alcoholic intolerance.
3. a person who are ineligible in the opinion of the investigator.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Okabe
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of Anesthesiology
Zip code 312-0057
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Email t-okabe@nms.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Okabe
Organization Hitachi, Ltd. Hitachinaka General Hospital
Division name Department of Anesthesiology
Zip code 312-0057
Address 20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN
TEL 029-354-5111
Homepage URL
Email t-okabe@nms.ac.jp

Sponsor
Institute Hitachi, Ltd. Hitachinaka General Hospital
Institute
Department

Funding Source
Organization None
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 the Hitachi Ltd., Hitachi General Hospital Research Ethics Committee
Address 2-1-1 jyonan-cho Hitachi-shi Ibaraki
Tel 029-423-8333
Email masahiro.miura.cz@hitachi.com

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 10 Month 11 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 10
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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 09 Day
Date of IRB
2018 Year 10 Month 01 Day
Anticipated trial start date
2018 Year 10 Month 11 Day
Last follow-up date
2019 Year 09 Month 30 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 10 Month 11 Day
Last modified on
2019 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039277

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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