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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033067
Receipt No. R000037703
Scientific Title Relationship between stool form and quality of life (QOL) in patients with chronic constipation: An internet questionnaire survey
Date of disclosure of the study information 2018/06/22
Last modified on 2019/04/04

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Basic information
Public title Relationship between stool form and quality of life (QOL) in patients with chronic constipation: An internet questionnaire survey
Acronym Relationship between stool form and quality of life (QOL): An internet survey
Scientific Title Relationship between stool form and quality of life (QOL) in patients with chronic constipation: An internet questionnaire survey
Scientific Title:Acronym Relationship between stool form and quality of life (QOL): An internet survey
Region
Japan

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

Objectives
Narrative objectives1 To elucidate the relationship between stool form and QOL in patients taking constipation remedies and understand the actual situationn of chronic constipation in Japan.
Basic objectives2 Others
Basic objectives -Others Survey on actual situation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between Bristol Stool Form Scale (BSFS) and Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL)
Key secondary outcomes 1) Relationship between BSFS and JPAC-QOL by age
2) Relationship between BSFS and JPAC-QOL by sex
3) Relationship between BSFS and JPAC-QOL by treatment agents
4) Relationship between BSFS and JPAC-QOL by medical department
5) Relationship between BSFS and JPAC-QOL by medication history
6) For patients with BSFS 6 or 7,
proportion of drug discontinuation or reduction
reason of drug discontinuation or reduction
thought on drug discontinuation or reduction

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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients aged >= 20 years old
2)Patients who have been diagnosed with chronic constipation before acquisition of consent and taking prescribed therapeutic agents
Key exclusion criteria 1) Patients with past history of gastrointestinal resection except appendectomy
2) Patients with current history of malignant diseases
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hidenori
Middle name
Last name Ohkubo
Organization Yokohama City University
Division name Hepatology and Gastroenterology Division
Zip code 236-0004
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 Atsushi
Middle name
Last name Nakajima
Organization Yokohama City University
Division name Hepatology and Gastroenterology Division
Zip code 236-0004
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, Hepatology and Gastroenterology Division
Institute
Department

Funding Source
Organization Mylan EPD G.K
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 Yokohama City University Ethics Committee for Medical and Health Research Involving Human Subjects
Address 5F Technocore Yokohama Kanazawa High-Tech Center 1-1-1 Fukuura, Kanazawa-ku, Yokohama City
Tel 045-370-7627
Email rinri@yokohama-cu.ac.jp

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 06 Month 22 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 05 Month 01 Day
Date of IRB
2018 Year 06 Month 01 Day
Anticipated trial start date
2018 Year 06 Month 21 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients registered in large scale pannel on the website will be asked to answer the internet questionnaire.

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2019 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037703

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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