UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single blinded study for the evaluation of bitterness of quinine hydrochloride and loperamide hydrochloride in healthy adult female and male volunteers
Title of the study (Brief title)	Study of the evaluation of bitter taste
Region	Japan

Condition
Condition	All of diseases that oral medication is prescribed
Classification by specialty	Medicine in general Geriatrics Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we measure the sensitivity for the bitterness of human to compared with that for taste instrument. The method could be used for the replacement of human sensory evaluation.
Basic objectives2	Others
Basic objectives -Others	Strengths of bitterness of quinine hydrochloride and loperamide hydrochloride will be compared.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A filter paper wetted with bitter substance will be placed on the tongue of volunteers and the strength of bitterness will be measured within 1 minute. After rinsing thoroughly in the mouth with water, then strengths of bitterness of quinine hydrochloride and loperamide hydrochloride will be measured.
Key secondary outcomes	In each volunteer, the concentration of loperamide hydrochloride which produces the same bitterness of quinine hydrochloride at 30 times higher concentration of the threshold value.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	All the volunteers will taste 9 and 7 samples including water in order to investigate the threshold concentration of quinine hydrochloride and loperamide hydrochloride for the recognition of bitterness.
Interventions/Control_2
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy female and male adult
Key exclusion criteria	1. People who are not like degustation 2. People who are allergic to drugs (quinine hydrochloride, loperamide hydrochloride) 3. people not eligible by the discretion of the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Ikezaki Hidekazu
Organization	Intelligent Sensor Technology, Inc.
Division name	No
Address	Onna 5-1-1, Atsugi, Kanagawa, 243-0032, Japan
TEL	046-296-6609
Email	ikezaki.hidekazu@insent.co.jp

Public contact
Name of contact person	Jun Kojima, PhD.
Organization	Medical and Health Resources Research Institute
Division name	No
Address	4-38-7, Higashi-Ikebukuro, Toshimaku-ku, Tokyo 170-0013, Japan
TEL	03(5904)8534
Homepage URL
Email	kojima@mhrri.com

Sponsor
Institute	Intelligent Sensor Technology, Inc.
Institute
Department

Funding Source
Organization	Intelligent Sensor Technology, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Medical and Health Resources Research Institute
Name of secondary funｄer(s)	No

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	一般社団法人医療健康資源開発研究所（東京都） 株式会社インテリジェントセンサーテクノロジー（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 07 Day
Last follow-up date	2016 Year 05 Month 20 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 06 Month 30 Day
Date analysis concluded	2016 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 05 Day
Last modified on	2016 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024528