UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022752 |
|---|---|
| Receipt number | R000026179 |
| Scientific Title | The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening |
| Date of disclosure of the study information | 2016/06/16 |
| Last modified on | 2016/06/15 13:46:45 |
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Basic information
Public title
The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Acronym
The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Scientific Title
The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Scientific Title:Acronym
The effects of Suvorexant, a novel orexin receptor antagonist, on physical and cognitive functions after nocturnal forced-awakening
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of Suvorexant on physical and cognitive functions after nocturnal forced-awakening
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The executive function 90 minutes after taking a pill (Stroop color-word test)
Key secondary outcomes
The physical functions 90 minutes after taking a pill (Balance ability, dexterity, reaction time, walking ability)
Polysomnography (Sleep latency, sleep architecture)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer placebo (lactose)
Interventions/Control_2
Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer placebo (lactose) - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg
Interventions/Control_3
Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer placebo (lactose)
Interventions/Control_4
Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer placebo (lactose) - Wash out (more than 2 days) - Administer Suvorexant 20 mg
Interventions/Control_5
Administer placebo (lactose) - Wash out (more than 2 days) - Administer Suvorexant 20 mg - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg
Interventions/Control_6
Administer placebo (lactose) - Wash out (more than 2 days) - Administer Brotizolam 0.25 mg - Wash out (more than 2 days) - Administer Suvorexant 20 mg
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Healthy men aged 18-40years old
2)Standard body size(BMI < 25 kg/m2)
3)Free from subjective sleep complaints (PSQI < 6 points)
4)Free from medical history of Sleep apnea syndrome
5)Participants who do not take sleeping pills
6)Participants whose sleep latency are 10 minutes or less
7)Morning people (MEQ > 59 points)
8)Habitual exercise 2 times or less a week for the past 6 months
9)Habitual drinking less than 3 times a week
10)No habitual smonking
Key exclusion criteria
1)Participants who are taking a pill to inhibit CYP3A
2)Acute angle crose glaucoma
3)Myasthenia gravis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-2660
okura@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Okura |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
029-853-2660
Homepage URL
okura@taiiku.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Faculty of health and sport sciences
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
International Institute for Integrative Sleep Medicine (IIIS)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 16 | 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
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
Preinitiation
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2016 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026179
