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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033671
Receipt No. R000038390
Scientific Title A study of biological factors relating to olfactory sense
Date of disclosure of the study information 2018/08/17
Last modified on 2020/02/12

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Basic information
Public title A study of biological factors relating to olfactory sense
Acronym Biological factors relating to olfactory sense
Scientific Title A study of biological factors relating to olfactory sense
Scientific Title:Acronym Biological factors relating to olfactory sense
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Oto-rhino-laryngology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the biological factors relating to olfactory sense
Basic objectives2 Others
Basic objectives -Others Exploratory
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Analysis of molecules in biological samples, measurement of olfactory sensitivity, assessment of odor quality, analysis of their correlations
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Sniffing odor A -> Sniffing odor C -> Sniffing odor B. On another day, sniffing odor D and E -> Sniffing odor H and I -> Sniffing odor F and G.
Interventions/Control_2 Sniffing odor C -> Sniffing odor B -> Sniffing odor A. On another day, sniffing odor F and G -> Sniffing odor D and E -> Sniffing odor H and I.
Interventions/Control_3 Sniffing odor B -> Sniffing odor A -> Sniffing odor C. On another day, sniffing odor H and I -> Sniffing odor F and G -> Sniffing odor D and E.
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
69 years-old >=
Gender Male and Female
Key inclusion criteria -Healthy males and females
-Subjects with no subjective symptoms of olfactory dysfunction
-Subjects who can visit specified location in Tokyo at specified time
Key exclusion criteria -Subjects with feeling rejection of inserting tweezers to nasal cavity
-Subjects with allergic to lidocaine
-Subjects with feeling rejection of anesthesia with lidocaine
-Subjects with feeling rejection of temporary pain and discomfort in nasal cavity
-Subjects with feeling rejection of sniffing uncomfortable odors
-Subjects who or whose families work for toiletries, cosmetics, eyeglasses, contact lens, pharmaceuticals, medical supplies, research, advertising, and media company, or medical services
-The pregnant and potentially pregnant, subjects in nursing
-Subjects with disease in nose
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Sakamoto
Organization Kao Corporation
Division name Kansei Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7683
Email sakamoto.takashi@kao.com

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Shirai
Organization Kao Corporation
Division name Kansei Science Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, Haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7682
Homepage URL
Email shirai.tomohiro@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Edogawa Hospital
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 +81-3-5630-9220
Email uesaka.toshio@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)
株式会社リサーチ・アンド・ディベロップメント(東京都)
社会福祉法人仁生社江戸川病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 17 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 30
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 07 Month 25 Day
Date of IRB
2018 Year 07 Month 25 Day
Anticipated trial start date
2018 Year 08 Month 17 Day
Last follow-up date
2018 Year 10 Month 04 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
2020 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038390

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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