UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019428 |
|---|---|
| Receipt number | R000022470 |
| Scientific Title | A study on the physiological effect of CBS-001 for sleeping |
| Date of disclosure of the study information | 2015/10/21 |
| Last modified on | 2016/08/02 10:20:02 |
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Basic information
Public title
A study on the physiological effect of CBS-001 for sleeping
Acronym
A study on the physiological effect of CBS-001 for sleeping
Scientific Title
A study on the physiological effect of CBS-001 for sleeping
Scientific Title:Acronym
A study on the physiological effect of CBS-001 for sleeping
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of CBS-001 on sleep quality
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electroencephalogram analysis in sleep(1 night)
Score of questionnaire before and after sleep
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep.
Interventions/Control_2
Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep.
Interventions/Control_3
Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(B) during sleep.
Interventions/Control_4
Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep.
Interventions/Control_5
Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with CBS-001(B) during sleep.
Interventions/Control_6
Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep.
Interventions/Control_7
Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep.
Interventions/Control_8
Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep.
Interventions/Control_9
Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(A) during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep.
Interventions/Control_10
Measuring electroencephalogram with CBS-001(B) during sleep. After 5days, Measuring electroencephalogram with no CBS-001 during sleep. After 5days, Measuring electroencephalogram with CBS-001(C) during sleep. After 5days, Measuring electroencephalogram with CBS-001(A) during sleep.
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male
Key exclusion criteria
-Subject taking medicine
-Short sleep time(under 270 minutes)
-Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Tsutsumi |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7568
tsutsumi.takehiro@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoya Kitamura |
Organization
Kao Corporation
Division name
R&D -Core Technology- Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
0285-68-7458
Homepage URL
kitamura.naoya@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 21 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | Month | 02 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No. of Interventions = 20
11 CBS-001(C)-CBS-001(A)-CBS-001(B)-no CBS-001
12 CBS-001(C)-CBS-001(A)-no CBS-001-CBS-001(B)
13 CBS-001(C)-CBS-001(B)-CBS-001(A)-no CBS-001
14 CBS-001(C)-CBS-001(B)-no CBS-001-CBS-001(A)
15 CBS-001(C)-no CBS-001-CBS-001(B)-CBS-001(A)
16 no CBS-001-CBS-001(A)-CBS-001(C)-CBS-001(B)
17 no CBS-001-CBS-001(B)-CBS-001(A)-CBS-001(C)
18 no CBS-001-CBS-001(B)-CBS-001(C)-CBS-001(A)
19 no CBS-001-CBS-001(C)-CBS-001(A)-CBS-001(B)
20 no CBS-001-CBS-001(C)-CBS-001(B)-CBS-001(A)
Management information
Registered date
| 2015 | Year | 10 | Month | 20 | Day |
Last modified on
| 2016 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022470
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