UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019991 |
|---|---|
| Receipt number | R000022742 |
| Scientific Title | The concentration measurement of acetaldehyde in human esophagus |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2023/07/28 05:48:15 |
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Basic information
Public title
The concentration measurement of acetaldehyde in human esophagus
Acronym
Esophageal Acetaldehyde study
Scientific Title
The concentration measurement of acetaldehyde in human esophagus
Scientific Title:Acronym
Esophageal Acetaldehyde study
Region
| Japan |
Condition
Condition
normal condition
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
concentration measurement of acetaldehyde in human esophagus
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The comparison of acetaldehyde concentration in esophageal biopsy specimen after alcohol intake between ALDH2-active and ALDH2-deficient subjects
Key secondary outcomes
1. The comparison of acetaldehyde concentration in esophageal biopsy specimen after alcohol intake between ALDH2-active and ALDH2-deficient subjects in administrating slowly L-cysteine releasing troches
2. The comparison of acetaldehyde concentration in blood, saliva, and esophageal biopsy specimen of ALDH2-active and ALDH2-deficient subjects in each condition of administration of slowly L-cysteine releasing troches and non-administration
3. The comparison of acetaldehyde concentration in esophageal and gastric biopsy specimen in each condition of administration of slowly L-cysteine releasing troches and non-administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration of L-cystein releasing troches
Interventions/Control_2
administration of placebo troches
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
Key inclusion criteria
1. The subjects with written informed consent
2. H. pylori-negative male subjects with 20 years or more
3. ALDH2-active or ALDH2-deficient subjects
Key exclusion criteria
1. Current smoker
2. The subjects after resection of gastrointestinal tract or truncal vagotomy
3. The subjects with ongoing therapy for any disease
4. The subjects with taking drugs except for L-cysteine troches during this study
5. The subjects who cannot drink any alcohol
6. The subjects with past history of allergy for any drug
7. The subjects with past history of liver, kidney or heart disease
8. The subjects that this study researcher regards as inappropriate for participating in this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Koike |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7171
tkoike@rd5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Waku |
| Middle name | |
| Last name | Hatta |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
022-717-7171
Homepage URL
waku-style@festa.ocn.ne.jp
Sponsor or person
Institute
Division of Gastroenterology, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Tohoku University Hospital
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-7145
rinri-2@proj.med.tohoku.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022742
