UMIN-ICDS Clinical Trial

Public title

Safety evaluation

Acronym

Safety evaluation

Scientific Title

Safety evaluation of intake of ONO-SR/PS for healthy adult part 2

Scientific Title:Acronym

Safety evaluation of intake of ONO-SR/PS part 2

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

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

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of test food containing 500mg of ONO-SR/PS for 4 weeks

Interventions/Control_2

Intake of test food containing 1,000mg of ONO-SR/PS for 4 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

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) BMI 18.5 or more and less than 25
(3) Subjects to measured ECG and stress/fatigue who are appliciable to following items
Height Male:155-185cm, Female:150-185cm
Bust Male:79-104cm, Female:79-102cm and bust less than E cup
Waist Male:less than 94cm, Female:less than 88cm

Key exclusion criteria

(1)Subjects who constantly use health food richly containing DHA, EPA, astaxanthin and shark liver oil involvement ingredient more than 1 times a week
(2)Subjects who having habit of fish and shellfish including fish roe more than 4 times a week
(3)Subjects having possibilities for emerging allergy relates to the study (e.g., fish, prawns, crab, and spawn)
(4)Subjects who having skin disease (e.g., contact dermatitis, and lacerations)
, or sensitive skin on the upper arm or upper body
(5)Subjects having a disease requiring treatment or a history of serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, endocrine disease, metabolic diseases, malignancy, and cancer) for which medication was required including implanted medical device such as cardiac pacemaker, and medical equipment necessary to sustain life such as a monitoring system
(6)Subjects who have diseases requiring medication, and treatment except dry eye and cavity protection, or have a history of serious diseases that required medication treatment
(7)Subjects who are judges as unsuitable for the study bases on the result of clinical and physical examination on preliminary examination
(8)Subjects who are judges as unsuitable for the study based on the results of lifestyle questionnaire
(9)Subjects judged as unsuitable for the study based on the results of clinical examination or cardiopulmonary abnormality in the past
(10)Subjects who are participating in other clinical research at the start of this study
(11)Subjects who are becoming pregnant or intend to become pregnant
(12)Subjects judged as unsuitable for the study by the investigator for other reasons

Target sample size

40

Name of lead principal investigator

1st name	Katsuya
Middle name
Last name	Kishikawa

Organization

ONO PHARMACEUTICAL CO., LTD.

Division name

Business Design Department, System promotion

Zip code

541-8564

Address

8-2, Kyutaromachi 1-chome, Chuo-ku, Osaka-shi, Osaka

TEL

06-6263-2924

Email

kishikawa@ono.co.jp

Name of contact person

1st name	Tamaki
Middle name
Last name	Furuhata

Organization

EP Mediate Co., Ltd.

Division name

Foods Department, Trial Planning Section 1

Zip code

162-0821

Address

Kagurazaka AK Building 7F, 1-8 Tsukudocho, Shinjuku-ku, Tokyo

TEL

070-3023-8207

Homepage URL

Email

furuhata.tamaki686@eps.co.jp

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name

Organization

ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

07

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

03

Month

23

Day

Date of IRB

2023

Year

03

Month

23

Day

Anticipated trial start date

2023

Year

04

Month

14

Day

Last follow-up date

2023

Year

07

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

04

Month

13

Day

Last modified on

2023

Year

07

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057930