UMIN-CTR Clinical Trial

Basic information
Public title	Residual effects of low dose of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study
Acronym	Residual effects of low dose of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study
Scientific Title	Residual effects of low dose of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study
Scientific Title:Acronym	Residual effects of low dose of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study
Region	Japan

Condition
Condition	insomnia
Classification by specialty	Geriatrics Psychiatry Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate hypnotics for safety in the elderly subjects using melatonin agonist ramelteon, orexin antagonist suvorexant and GABAa agonist zolpidem.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG(from 23:00 to 6:00)
Key secondary outcomes	Measures of objective parameters (Timed up and Go test, Functional Reach Test, body sway test, critical flicker fusion test, simple discrimination reaction test and short-term memory test) and subjective ratings were obtained every 2 hour from 4:00 to 16:00.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	suvorexant 10 mg, zolpidem 5mg, ramelteon 4mg or placebo
Interventions/Control_2	a single-blind pharmacokinetic assessment
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	63 years-old <
Age-upper limit	76 years-old >
Gender	Male and Female
Key inclusion criteria	Healthy elderly people
Key exclusion criteria	The subject who took hypnotics within the previous year, are addicted to drugs or alcohol, or had a history of repeated falls or a fracture within the past two years.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Sachiko Middle name Last name Uemura
Organization	Akita University Graduate School of Medicine
Division name	Department of Physical Therapy
Zip code	010-8543
Address	1-1-1 Hondo, Akita-city, Akita
TEL	018-884-6529
Email	uemura@hs.akita-u.ac.jp

Public contact
Name of contact person	1st name Sachiko Middle name Last name Uemura
Organization	Akita University Graduate School of Medicine
Division name	Department of Physical Therapy
Zip code	010-8543
Address	1-1-1 Hondo, Akita-city, Akita
TEL	018-884-6529
Homepage URL
Email	uemura@hs.akita-u.ac.jp

Sponsor
Institute	Akita University Graduate School of Medicine
Institute
Department

Funding Source
Organization	JSPS KAKENHI Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Akita University Graduate School of Medicine
Address	1-1-1 Hondo, Akita-city, Akita
Tel	018-884-6500
Email	soken@hos.akita-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 15 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	14
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 08 Month 01 Day
Date of IRB	2016 Year 08 Month 29 Day
Anticipated trial start date	2016 Year 08 Month 30 Day
Last follow-up date	2022 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 03 Month 14 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053801