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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021789
Receipt No. R000024528
Scientific Title Single blinded study for the evaluation of bitterness of quinine hydrochloride and loperamide hydrochloride in healthy adult female and male volunteers
Date of disclosure of the study information 2016/04/05
Last modified on 2016/08/31

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Basic information
Public title Single blinded study for the evaluation of bitterness of quinine hydrochloride and loperamide hydrochloride in healthy adult female and male volunteers
Acronym Study of the evaluation of bitter taste
Scientific Title Single blinded study for the evaluation of bitterness of quinine hydrochloride and loperamide hydrochloride in healthy adult female and male volunteers
Scientific Title:Acronym 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
1st name
Middle name
Last name Ikezaki Hidekazu
Organization Intelligent Sensor Technology, Inc.
Division name No
Zip code
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
1st name
Middle name
Last name Jun Kojima, PhD.
Organization Medical and Health Resources Research Institute
Division name No
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

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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