UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039268
Receipt number R000044783
Scientific Title Safety evaluation of excessive intake of ONO-SR/AST for healthy adults
Date of disclosure of the study information 2021/04/21
Last modified on 2020/05/08 13:37:31

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Basic information

Public title

Safety evaluation

Acronym

Safety evaluation

Scientific Title

Safety evaluation of excessive intake of ONO-SR/AST for healthy adults

Scientific Title:Acronym

Safety evaluation of excessive intake of ONO-SR/AST

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of ONO-SR/AST daily intake, for 4 weeks

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hematologic test, Blood biochemistry test, Urine test, Blood pressure/pulsation, Weight/body mass index, Medical Interview, before and 2, 4 weeks after intake and 2 weeks after the end of intake period and Adverse events thorough the study

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of ONO-SR/AST, recommended daily intake, for 4 weeks

Interventions/Control_2

Intake of ONO-SR/AST 2-fold quantity of recommended daily intake, for 4 weeks

Interventions/Control_3

Intake of ONO-SR/AST 5-fold quantity of recommended daily intake, for 4 weeks

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

Healthy males and females from 20 to 64 years of age

Key exclusion criteria

(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(3) Subjects having possibilities for emerging allergy related to the study
(4) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(5) Subjects having a drug dependence, alcohol dependence requiring treatment or a history of serious alcohol dependence
(6) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(7) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

30


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 Takashi
Middle name
Last name Nakagawa

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

t.nakagawa@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

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taitou-ku, Tokyo

Tel

03-6455-0880

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 04 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

2019 Year 12 Month 26 Day

Date of IRB

2019 Year 12 Month 26 Day

Anticipated trial start date

2020 Year 01 Month 29 Day

Last follow-up date

2020 Year 04 Month 21 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 01 Month 27 Day

Last modified on

2020 Year 05 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044783


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name