UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of drug on circadian rhythm in healthy adult male
Title of the study (Brief title)	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	Shigekazu Higuchi
Organization	Kyushu University
Division name	Graduate School of Human Science
Address	4-9-1 Shiobaru, Minami-ku, Fukuoka
TEL	092-553-4523
Email	higu-s@design.kyushu-u.ac.jp

Public contact
Name of contact person	Shigekazu Higuchi
Organization	Kyushu University
Division name	Graduate School of Human Science
Address	4-9-1 Shiobaru, Minami-ku, Fukuoka
TEL	092-553-4523
Homepage URL
Email	higu-s@design.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 05 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033273