UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029123 |
|---|---|
| Receipt number | R000033273 |
| Scientific Title | Effect of drug on circadian rhythm in healthy adult male |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2017/12/26 18:13:24 |
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Basic information
Public title
Effect of drug on circadian rhythm in healthy adult male
Acronym
Effect of drug on circadian rhythm
Scientific Title
Effect of drug on circadian rhythm in healthy adult male
Scientific Title:Acronym
Effect of drug on circadian rhythm
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the effect of drug on circadian rhythm
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dim Light Melatonin Onset (DLMO)
Key secondary outcomes
Actigraph
OSA sleep inventory MA version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants 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
A single dose of drug
Interventions/Control_2
A single dose of placebo
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | > |
Gender
Male
Key inclusion criteria
Male university undergraduate or graduate students who have standard sleep habits
Key exclusion criteria
1)Subjects who take drug
2)Subjects who are shift worker or night worker
3)Subjects whose DLMO was not detected by screening test
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigekazu Higuchi |
Organization
Kyushu University
Division name
Graduate School of Human Science
Zip code
Address
4-9-1 Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
higu-s@design.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigekazu Higuchi |
Organization
Kyushu University
Division name
Graduate School of Human Science
Zip code
Address
4-9-1 Shiobaru, Minami-ku, Fukuoka
TEL
092-553-4523
Homepage URL
higu-s@design.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUSEIKAI HAKATA CLINIC
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | 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
| 2017 | Year | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033273
