UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey
Title of the study (Brief title)	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	Hidenori Ohkubo
Organization	Yokohama City University
Division name	Hepatology and Gastroenterology Division
Address	3-9 Fukuura Kanazawa-ku Yokohama City
TEL	045-787-2640
Email	ohkuboh@yokohama-cu.ac.jp

Public contact
Name of contact person	Atsushi Nakajima
Organization	Yokohama City University
Division name	Hepatology and Gastroenterology Division
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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