UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The self-reporting-questionnaire for the Chronic constipation patients in Japan.
Title of the study (Brief title)	The self-reporting-questionnaire for the Chronic constipation patients in Japan.
Region	Japan

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

Objectives
Narrative objectives1	The ROME classification is used for functional constipation, one of the chronic constipation. But, The ROME classification is not so used in Japan. The aim of our study is the development of the self-reporting-questionnaire for the chronic constipation patients in Japan.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Abdominal symptom
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who gives written informed consent
Key exclusion criteria	Patient who doesn't gives written informed consent
Target sample size	400

Research contact person
Name of lead principal investigator	Atsushi Nakajima
Organization	Yokohama City University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	Hiroshi Iida
Organization	Yokohama City University School of Medicine
Division name	Department of Medical Education
Address	3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL	045-787-2800
Homepage URL
Email	hiro0905@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	The Japanese Society of Gastroenterology
Organization
Division
Category of Funding Organization	Non profit foundation
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	横浜市立大学附属病院（神奈川県）、群馬大学医学部付属病院（群馬県）

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date	2019 Year 09 Month 04 Day
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	We study a questionnaire consisting of 55 question items for patients who had a checkup at gastroenterological medicine, and pick up about 10 useful question items in this questionnaire. The development of the self-reporting-questionnaire for the chronic constipation patients in Japan is the aim of this study.

Management information
Registered date	2014 Year 09 Month 29 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017300