臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 19, 2021
Last modified on	Feb. 28, 2025
Trial ID	jRCT2031200373

Scientific Title	A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.
Public Title	A clinical pharmacology study of TS-142 in patients with obstructive sleep apnea hypopnea.

Contact for Scientific Queries	Name	Mita Seiji
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp
Contact for Public Queries	Name	Development Management Development Headquarters
	Affiliation	Taisho Pharmaceutical Co., LTD.
	Address	3-24,1, Takada, Toshima-Ku, Tokyo
	Telephone	+81-3-3985-1118
	E-mail	shu_chiken@taisho.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Feb. 22, 2021
Actual date of first enrollment		Feb. 24, 2021
Target sample size		40
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	crossover assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Subjects must meet all of the following criteria to be included in this study: - Japanese male and female, age 20 years or older at the time of informed consent - Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea - Other protocol defined inclusion criteria could apply
	Exclusion Criteria	Subjects who meet any of the following criteria will be excluded from this study: - Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder - Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea - Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at visit 1 - Other protocol defined exclusion criteria could apply
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Obstructive sleep apnea hypopnea
Intervention(s)		Single oral doses of 10 mg of TS-142 and matching placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Apnea hypopnea index
Secondary Outcome(s)		Saturation of percutaneous oxygen

Primary Sponsor	Taisho Pharmaceutical Co., LTD.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	HOUEIKAI Institutional Review Board
Address	3-28-3, Ikebukuro, Toshima-ku, Tokyo
Telephone	+81-3-5396-4530
E-Mail	kanai_shinichiro@seri.co.jp
Approval Status	Approval
Date of approval	Feb. 04, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04746105
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
6	Feb. 28, 2025	(this page)	Changes
5	Oct. 18, 2022	Detail	Changes
4	Mar. 09, 2022	Detail	Changes
3	Dec. 01, 2021	Detail	Changes
2	Mar. 11, 2021	Detail	Changes
1	Feb. 19, 2021	Detail

List of change history