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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033323
Receipt No. R000037979
Official scientific title of the study Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity; Observational study using data from Japanese National Health and Wellness Survey
Date of disclosure of the study information 2018/07/09
Last modified on 2018/07/08

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Basic information
Official scientific title of the study Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity; Observational study using data from Japanese National Health and Wellness Survey
Title of the study (Brief title) Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity in Japan
Region
Japan

Condition
Condition Chronic Constipation
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to describe and quantify Health-related quality of life (HRQOL) and Work and activity productivity loss and Indirect cost of chronic constipation (CC) in Japanese patients.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Health-related quality of life (HRQOL)
-Physical Component Score(PCS) from the SF-12v2
-Mental Component Score(MCS) from the SF-12v2
-EQ-5D
Key secondary outcomes

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Respondents who completed the SF-12v2, the EQ-5D and the WPAI Questionnaire
Key exclusion criteria none
Target sample size 30001

Research contact person
Name of lead principal investigator Hiroto Miwa
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Address 1-1,Mukogawa-cho,Nishinomiya. Hyogo, Japan 663-8501
TEL +81-798-45-6662
Email miwahgi@hyo-med.ac.jp

Public contact
Name of contact person Toshihiko Tomita
Organization Hyogo College of Medicine
Division name Division of Gastroenterology, Department of Internal Medicine
Address 1-1, Mukogawa-cho, Nishinomiya. Hyogo, Japan 663-8501
TEL +81-798-45-6662
Homepage URL
Email tomita@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
2018 Year 07 Month 09 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 03 Month 16 Day
Anticipated trial start date
2018 Year 09 Month 07 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 The aim of this study is to describe and quantify Health-related quality of life (HRQoL) and Work and activity productivity loss and Indirect cost of chronic constipation (CC) in Japanese patients.

Management information
Registered date
2018 Year 07 Month 08 Day
Last modified on
2018 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037979

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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