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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230362

Enrollment

Registered

2023-09-25

Start date

2023-11-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with delirium, psychomotor agitation, or irritability

Interventions

HP-6050 group: Single dose of HP-6050 (Microneedle) Placebo group: Single dose of HP-6050 placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Japanese patients aged 18 years or older - Patients with risk factors such as delirium

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Sedation scale	—

Secondary

Measure	Time frame
Change from baseline in sedation scale Adverse event	—

Contacts

Public ContactContact for Clinical Trial Information Clinical Development Department

Hisamitsu Pharmaceutical Co., Inc.

shikenjoho@hisamitsu.co.jp+81-3-5293-1734

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026