UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034154
Receipt number R000038934
Scientific Title Relationship between self-recognition of constipation and actual codition of bowel movement in Japanese population: An internet questionnaire survey
Date of disclosure of the study information 2018/09/15
Last modified on 2018/09/14 22:42:39

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Basic information

Public title

Relationship between self-recognition of constipation and actual codition of bowel movement in Japanese population: An internet questionnaire survey

Acronym

Relationship between self-recognition of constipation and actual codition of bowel movement

Scientific Title

Relationship between self-recognition of constipation and actual codition of bowel movement in Japanese population: An internet questionnaire survey

Scientific Title:Acronym

Relationship between self-recognition of constipation and actual codition of bowel movement

Region

Japan


Condition

Condition

chronic constipation

Classification by specialty

Medicine in general Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To elucidate the concordance rate of self-recognition of constipation and meeting the RomeIV criteria in Japanese adult population

Basic objectives2

Others

Basic objectives -Others

Internet survey on actual situation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The proportion of meeting the RomeIV criteria in subjects with self-recognition of constipation and those without

Key secondary outcomes

Difference of the views on bowel movement and constipation between subjects with self-recognition of constipation and those without


Base

Study type

Observational


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

69 years-old >=

Gender

Male and Female

Key inclusion criteria

Subjects who live in Japan

Key exclusion criteria

1)Persons engaged in pharmaceuticals and medical devices industry
2)Persons engaged in advertisement and broadcasting industry
3)Persons engaged in research and consulting industry

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hidenori Ohkubo

Organization

Yokohama City University

Division name

Hepatology and Gastroenterology Division

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

ohkuboh@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Atsushi Nakajima

Organization

Yokohama City University

Division name

Hepatology and Gastroenterology Division

Zip code


Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL


Email

nakajima-tky@umin.ac.jp


Sponsor or person

Institute

Yokohama City University, Hepatology and Gastroenterology Division

Institute

Department

Personal name



Funding Source

Organization

Kyowa Chemical Industry Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Japan Toilet Labo.

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 09 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


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

Open public recruiting

Date of protocol fixation

2018 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 09 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Monitors registered in marketing research company MARSH will be asked to answer the internet questionnaire.


Management information

Registered date

2018 Year 09 Month 14 Day

Last modified on

2018 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038934


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name