臨床研究等提出・公開システム

Date of registration	Sept. 25, 2023
Last modified on	Dec. 06, 2024
Trial ID	jRCT2031230362

Scientific Title	Phase II study of HP-6050 in patients with delirium, psychomotor agitation, and irritability
Public Title	Phase II study of HP-6050 in patients with delirium, psychomotor agitation, and irritability

Contact for Scientific Queries	Name	Inakura Hiroshi
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp
Contact for Public Queries	Name	Clinical Development Department Contact for Clinical Trial Information
	Affiliation	Hisamitsu Pharmaceutical Co., Inc.
	Address	2-4-1 Marunouchi, Chiyoda-ku, Tokyo
	Telephone	+81-3-5293-1734
	E-mail	shikenjoho@hisamitsu.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 18, 2023
Actual date of first enrollment		Nov. 21, 2023
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Japanese patients aged 18 years or older - Patients with risk factors such as delirium
	Exclusion Criteria	- Patients with a serious disease that is life-threatening or requires emergency treatment - Patients who cannot undergo evaluation and observation under hospitalization - Patients who are not considered by the physician to require sedation with drugs
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patients with delirium, psychomotor agitation, or irritability
Intervention(s)		HP-6050 group: Single dose of HP-6050 (Microneedle) Placebo group: Single dose of HP-6050 placebo
Primary Outcome(s)		Sedation scale
Secondary Outcome(s)		Change from baseline in sedation scale Adverse event

Primary Sponsor	Hisamitsu Pharmaceutical Co., Inc.

Name of Certified Review Board	Tokushukai Group Institutional Review Board
Address	1-3-1, Kudan-minami, Chiyoda-ku, Tokyo
Telephone	+81-3-3263-4801
E-Mail	irb@mirai-iryo.com
Approval Status	Approval
Date of approval	Sept. 22, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Dec. 06, 2024	(this page)	Changes
3	Sept. 17, 2024	Detail	Changes
2	Mar. 28, 2024	Detail	Changes
1	Sept. 25, 2023	Detail

List of change history