UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015275
Receipt number R000017300
Scientific Title The self-reporting-questionnaire for the Chronic constipation patients in Japan.
Date of disclosure of the study information 2014/10/01
Last modified on 2018/06/22 11:18:26

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Basic information

Public title

The self-reporting-questionnaire for the Chronic constipation patients in Japan.

Acronym

The self-reporting-questionnaire for the Chronic constipation patients in Japan.

Scientific Title

The self-reporting-questionnaire for the Chronic constipation patients in Japan.

Scientific Title:Acronym

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

1st name
Middle name
Last name Atsushi Nakajima

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


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

1st name
Middle name
Last name Hiroshi Iida

Organization

Yokohama City University School of Medicine

Division name

Department of Medical Education

Zip code


Address

3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan

TEL

045-787-2800

Homepage URL


Email

hiro0905@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2014 Year 09 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017300


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name