UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041059
Receipt number R000046890
Scientific Title A study for the effect of intake of ONO-SR/AST-DA on sleep
Date of disclosure of the study information 2021/07/15
Last modified on 2021/07/15 12:37:46

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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 or person

Institute

TTC Co., Ltd

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046890


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name