UMIN-CTR 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
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
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
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/ctr_e/ctr_view.cgi?recptno=R000038934
