UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021789 |
|---|---|
| Receipt number | 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 00:18:30 |
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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
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
kojima@mhrri.com
Sponsor or person
Institute
Intelligent Sensor Technology, Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024528
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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