臨床研究等提出・公開システム

Scientific Title	Test to evaluate the influence of taste on the feeling of taking medication
Public Title	Test to evaluate the influence of taste on the feeling of taking medication

Completion date	April. 26, 2024
Result actual enrolment	60
Baseline Characteristics	Healthy adults
Participant flow	Planned: 60 subjects, Final: 60 subjects
Adverse events	none
Outcome measures	The questionnaire results and electromyogram results confirmed that swallowing difficulty increased with increasing bitterness (caffeine) concentration.The questionnaire results showed that swallowing difficulty increased with increasing sweetness (sucrose) concentration, but there was no high correlation with the electromyogram results.
Brief summary	It was suggested that unpleasant tastes in the oral cavity affect swallowing difficulty and swallowing muscle activity. This was particularly evident for bitter tastes, which are considered to be harmful to humans, but this tendency was limited for sweet tastes, which are considered to be beneficial to humans.
Date of posting of results summaries	Sept. 20, 2025

Plan to share IPD	No
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCT1070240002

Contact for Scientific Queries	Name	Shouji Yokota
	Affiliation	Sawai Pharmaceutical Co., Ltd.
	Address	5-2-30 Miyahara, Yodogawa-ku, Osaka-shi, Osaka Prefecture
	Telephone	+81-6-6105-5728
	E-mail	shouji.yokota@sawai.co.jp
Contact for Public Queries	Name	Tomohisa Kato
	Affiliation	Sawai Pharmaceutical Co., Ltd.
	Address	5-2-30 Miyahara, Yodogawa-ku, Osaka-shi, Osaka Prefecture
	Telephone	+81-6-6105-5728
	E-mail	t.kato@sawai.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		April. 01, 2024
Actual date of first enrollment		April. 01, 2024
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Japanese people in their 20s or 40s at the time of consent
	Exclusion Criteria	1.Those taking xanthine drugs, MAO inhibitors, and cimetidine 2.Persons with gastric ulcer or a history thereof 3. Persons attending the hospital for treatment of heart disease 4. Persons attending the hospital for treatment of glaucoma 5. Pregnant women, lactating women, and those wishing to become pregnant 6. People who are unable to consume caffeine or who become unwell due to caffeine intake (including intake of coffee, green tea, etc.)
	Age Minimum	20age 0month 0week old over
	Age Maximum	49age 11month 4week old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		None (healthy adult)
Intervention(s)		Taking caffeine and sucrose solutions Measurement of surface electromyogram
Health Condition(s) Keyword		healthy adult
Intervention(s) Keyword		Measurement of surface electromyogram
Primary Outcome(s)		Questionnaire on usage feeling Electromyogram measurement results
Secondary Outcome(s)		none

Primary Sponsor	Sawai Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor	Sawai Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Source of Monetary Support	Sawai Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hakata Clinic Clinical Trial Review Committee
Address	6-18 Tenayamachi, Hakata-ku, Fukuoka City, Fukuoka Prefecture, Fukuoka
Telephone	+81-92-283-7701
Approval Status	Approval
Date of approval	Mar. 22, 2024

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 15, 2025	(this page)	Changes
1	April. 03, 2024	Detail

List of change history