UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047169 |
|---|---|
| Receipt number | R000053801 |
| Scientific Title | Residual effects of low dose of suvorexant, zolpidem and ramelteon in healthy elderly subjects: a randomized double-blind study |
| Date of disclosure of the study information | 2022/03/15 |
| Last modified on | 2022/03/14 16:25:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
uemura@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053801
