UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040575
Receipt number R000046313
Scientific Title Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.
Date of disclosure of the study information 2020/06/19
Last modified on 2020/11/30 09:01:29

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Basic information

Public title

Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.

Acronym

Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.

Scientific Title

Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.

Scientific Title:Acronym

Quality verification testing for identified the location of seamless capsule dissolution in digestive tract.

Region

Japan


Condition

Condition

Not applicable (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarify the disintegration site of the seamless capsules.

Basic objectives2

Others

Basic objectives -Others

Performance evaluation of seamless capsules.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Difference the process of the disintegration caused by constitution of seamless capsules.

Key secondary outcomes

Estimation of the transit time in digestive tract.


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

50 years-old >

Gender

Male and Female

Key inclusion criteria

(1) Japanese healthy males and females checked by health examination at the company.
(2) Subjects aged, 20 to 50 years old at the informed consent.
(3) Non-pregnant females.

Key exclusion criteria

(1) Subjects who have gastrointestinal disturbance based on questionary at the volunteer recruitment.
(2) Subjects who have potential effect on transit time of digestive tract (Gastrectomy etc).
(3) Subjects who have histories of gastrointestinal ulcer.
(4) Subjects who have disease histories of gastrointestinal tract during a latest month or have symptoms at the volunteer recruitment.
(5) Subjects who have histories of serious illness (Ischemic heart disease etc).
(6) Subjects who have histories of serious cardiac dysfunction or blood abnormalities.
(7) Subjects judged as unsuitable for the study by the investigator for mental illness or behavioral abnormalities.
(8) The pregnant or lactating females.
(9) Subjects who have been determined ineligible by the investigator.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shunji
Middle name
Last name Fujimori

Organization

Nippon Medical School Chiba Hokusoh Hospital

Division name

Gastroenterological Medicine

Zip code

270-1694

Address

1715, kamagari, Inzai-City, Chiba

TEL

0476-99-1111

Email

s-fujimori@nms.ac.jp


Public contact

Name of contact person

1st name Mamiko
Middle name
Last name Kohno

Organization

Morishita Jintan Co., Ltd.

Division name

Health Care Product Department

Zip code

101-0043

Address

Ascend Kanda Building 6F, 10-2, Tomiyama-cho Kanda, Chiyoda-ku, Tokyo

TEL

03-6206-8138

Homepage URL


Email

m_kohno@jintan.co.jp


Sponsor or person

Institute

Nippon Medical School Chiba Hokusoh Hospital

Institute

Department

Personal name



Funding Source

Organization

Morishita Jintan 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

Nippon Medical School Chiba Hokusoh Hospital

Address

1715, kamagari, Inzai-City, Chiba

Tel

0476-99-1111

Email

s-fujimori@nms.ac.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

2020 Year 06 Month 19 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 10 Month 21 Day

Date of IRB

2019 Year 12 Month 04 Day

Anticipated trial start date

2020 Year 06 Month 19 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 05 Month 29 Day

Last modified on

2020 Year 11 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name