UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033671
Receipt number 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 17:00:19

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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 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

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

Value
https://center6.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