UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033670 |
|---|---|
| Receipt number | R000038389 |
| Scientific Title | A study of relationship between odor perception and the genotype of an olfactory receptor gene |
| Date of disclosure of the study information | 2018/08/20 |
| Last modified on | 2019/07/12 09:45:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of relationship between odor perception and the genotype of an olfactory receptor gene
Acronym
A study of relationship between odor perception and the genotype of an olfactory receptor gene
Scientific Title
A study of relationship between odor perception and the genotype of an olfactory receptor gene
Scientific Title:Acronym
A study of relationship between odor perception and the genotype of an olfactory receptor gene
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 relationship between odor perception and 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
Evaluation of odor sensitivity and impression 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
| Gene |
Interventions/Control_1
We are going to select the subjects who have wild-type / wild-type genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
Interventions/Control_2
We are going to select the subjects who have wild-type / mutant genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
Interventions/Control_3
We are going to select the subjects who have mutant / mutant genotype about a certain missense mutation of olfactory receptor gene X and get them evaluate three odors.
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
Subjects who feel themselves normal about odor perception
Key exclusion criteria
-Subjects with a chronic disease, and either attending the hospital or taking medicine
-Subjects with odor perception disorder
-Subjects who dislike perfume, or other odor substances
-Subjects who are hypersensitive to chemicals
-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 | |
| Middle name | |
| Last name | Naoko Saito |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7683
saito.nao@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dan Takase |
Organization
Kao Corporation
Division name
Kansei Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7685
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
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 20 | 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
| 2018 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 06 | 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 | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038389
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
