UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000033323 |
|---|---|
| Receipt number | R000037979 |
| Scientific Title | 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 08:15:48 |
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Basic information
Public title
Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity; Observational study using data from Japanese National Health and Wellness Survey
Acronym
Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity in Japan
Scientific Title
Impact of Chronic Constipation on Health-Related Quality of Life and Work Productivity; Observational study using data from Japanese National Health and Wellness Survey
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroto Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1,Mukogawa-cho,Nishinomiya. Hyogo, Japan 663-8501
TEL
+81-798-45-6662
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Tomita |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology, Department of Internal Medicine
Zip code
Address
1-1, Mukogawa-cho, Nishinomiya. Hyogo, Japan 663-8501
TEL
+81-798-45-6662
Homepage URL
tomita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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)
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 | 07 | Month | 09 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 03 | Month | 16 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037979
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
