UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040703 |
|---|---|
| Receipt number | R000046464 |
| Scientific Title | The analysis of influence by genotype of an olfactory receptor gene |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2020/09/24 08:50:23 |
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Basic information
Public title
A study of olfactory receptors
Acronym
A study of olfactory receptors
Scientific Title
The analysis of influence by genotype of an olfactory receptor gene
Scientific Title:Acronym
A study of olfactory receptors
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To discover influence of the genotype of an olfactory receptor gene
Basic objectives2
Others
Basic objectives -Others
Mechanism analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare physiological difference among the three different genotypes of an olfactory receptor gene
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
We are going to select the subjects who have genotype A about olfactory receptor gene X and measure their physiological states.
Interventions/Control_2
We are going to select the subjects who have genotype B about olfactory receptor gene X and measure their physiological states.
Interventions/Control_3
We are going to select the subjects who have genotype C about olfactory receptor gene X and measure their physiological states.
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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy males and females
Key exclusion criteria
-Subjects with a chronic disease, and either attending the hospital or taking medicine
-Subjects undergoing a hormone replace therapy
-Subjects who are pregnant or likely to be.
-Subjects who are lactating
-Subjects with an infectious disease
-Subjects considered unsuitable to participate in this study by the investigators of this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Sakamoto |
Organization
Kao Corporation
Division name
Sensory Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7684
takashi.sakamoto@kao.com
Public contact
Name of contact person
| 1st name | Dan |
| Middle name | |
| Last name | Takase |
Organization
Kao Corporation
Division name
Sensory Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7684
Homepage URL
takase.dan@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 12 | 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
60
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
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046464
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
