UMIN-CTR Clinical Trial

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
Last 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
1st 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