UMIN-CTR Clinical Trial

Basic information
Public title	A study for the effect of intake of ONO-SR/AST-DA on sleep
Acronym	A study for the effect of intake of ONO-SR/AST-DA on sleep
Scientific Title	A study for the effect of intake of ONO-SR/AST-DA on sleep
Scientific Title:Acronym	A study for the effect of intake of ONO-SR/AST-DA on sleep
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on quality of sleep of ONO-SR/AST-DA daily intake, for 12 weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Quality of sleep measured by electroencephalograph
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test food daily intake, for 12 weeks
Interventions/Control_2	Intake of placebo daily intake, for 12 weeks
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 20 to 64 years of age (2) A person with a score of 6 or more on Pittsburgh Sleep Questionnaire
Key exclusion criteria	1. Subjects who are currently receiving medication, dietary guidance, or exercise therapy 2. Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress 3. Subjects who were under treatment or have a history of serious diseases 4. Subjects who have history of mental illness, chronic fatigue syndrome, insomnia 5. Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome 6. Subjects with nocturnal urination 7. Subjects who are likely to cause skin irritation due to electrode adhesive pads 8. Subjects who have a disease that requires constant medication, subjects with serious diseases that require medication, and subjects with a history of serious diseases 9. Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress 10. Subjects who constantly use food richly containing involvement ingredient 11. Subjects who engage in manual labor 12. Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire 13. Subjects who plan to travel abroad or travel abroad during the research period, or who plan to travel on long domestic business trips or domestic trips for more than one week in a row 14. Subjects who have experienced abnormal clinical test values or cardiopulmonary function and have been judged to have problems participating in the study 15. Subjects at risk of developing allergy in relation to the study 16. Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 17. Subjects who have participated in other clinical study within the last one month prior to the current study 18. Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 19. Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yasunari Middle name Last name Noda
Organization	ONO PHARMACEUTICAL CO., LTD.
Division name	Business Design Department
Zip code	541-8564
Address	8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka
TEL	06-6263-2924
Email	ya.noda@ono.co.jp

Public contact
Name of contact person	1st name Shingo Middle name Last name Yamamichi
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	Ono Pharmaceutical co.,ltd
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	Medical Station Clinic Research Ethics Committee
Address	3-12-8, Takaban, Meguroku, Tokyo
Tel	03-6452-2712
Email	t.saito@ttc-smo.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	2021 Year 07 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	80
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	2020 Year 07 Month 09 Day
Date of IRB	2020 Year 07 Month 09 Day
Anticipated trial start date	2020 Year 07 Month 12 Day
Last follow-up date	2020 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 07 Month 10 Day
Last modified on	2021 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046890