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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036006
Receipt No. R000041012
Scientific Title Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey
Date of disclosure of the study information 2019/02/26
Last modified on 2019/02/27

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Basic information
Public title Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey
Acronym Defecation desire in patients with chronic constipation(CC) in Japan; An internet survey
Scientific Title Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey
Scientific Title:Acronym Defecation desire in patients with chronic constipation(CC) in Japan; An internet survey
Region
Japan

Condition
Condition chronic constipation(CC)
Classification by specialty
Medicine in general Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 )To investigate whether a defecation desire is more reduced in patients with CC who meet Rome-IV criteria than non-constipated people.
2)To elucidate the actual situation of post-treatment symptoms in CC patients taking prescribed medication.
Basic objectives2 Others
Basic objectives -Others Survey on actual situation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation desire score in the CC group who meet Rome-IV criteria and non-CC group with age and gender matching
Key secondary outcomes For all subjects under no treatment situation,
1)Bristol stool form scale
2)Frequency of bowel movement
3)Frequency of difficulty in defecation
4)Frequency of incomplete evacuation
5)Frequency of abdominal pain
6)Time required for evacuation
7)Manual maneuvers to facilitate defecation
8)Number of times of no defecation even if going to the bathroom per 24 hours
9)Disease duration
10)Abdominal pain during defecation
11)Abdominal bloating during defecation
12)Rome-IV criteria
13)Presence or absence of medication for constipation

For patients with CC meeting Rome-IV criteria and taking prescribed medication,
1)Type of drugs used in last one week
2)Disease duration
3)Reason for visit a hospital/clinic
4)Duration of using the over-the-counter drugs before visiting a hospital/clinic
5)Bristol stool form scale in last one week
6)Frequency of defecation desire in last one week
7)Frequency of bowel movement in last one week
8)Frequency of difficulty in defecation in last one week
9)Frequency of incomplete evacuation in last one week
10)Frequency of abdominal pain in last one week
11)Time required for evacuation in last one week
12)Manual maneuvers to facilitate defecation in last one week
13)Number of times of no defecation even if going to the bathroom per 24 hours in last one week
14)Satisfaction for the using drugs in last one week

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Japanese monitor registered in the online panel owned by Rakuten Insight
2) Subjects aged >= 20 years old and <80 years old
Key exclusion criteria 1)Subjects engaged in pharmaceuticals and medical devices industry
2)Subjects engaged in advertisement and broadcasting industry
3)Subjects engaged in research and consulting industry
Target sample size 24000

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
Institute Yokohama City University
Institute
Department

Funding Source
Organization Mochida Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Rakuten Insight, Inc
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
2019 Year 02 Month 26 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
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Subjects registered in the large scale online pannel owned by Rakuten Insight, Inc. will be asked to answer the internet questionnaire.

Management information
Registered date
2019 Year 02 Month 25 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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