UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031784
Receipt number R000036234
Scientific Title Survey on chronic constipation practice in Japan
Date of disclosure of the study information 2018/03/20
Last modified on 2021/02/18 10:58:52

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Survey on chronic constipation practice in Japan

Acronym

Survey on chronic constipation practice

Scientific Title

Survey on chronic constipation practice in Japan

Scientific Title:Acronym

Survey on chronic constipation practice

Region

Japan


Condition

Condition

chronic constipation

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the clinical significance of evaluating the stool form based on Bristol scale

Basic objectives2

Others

Basic objectives -Others

Bristol scale
Patient Assessment of Constipation Quality of Life (PAC-QOL)
Constipation Scoring System; CSS
SF-8

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The association between stool form and Patient Assessment of Constipation Quality of Life (PAC-QOL)

Key secondary outcomes

The association between stool form and bowel movement.
The association between stool form and difficulty of defecation
Constipation Scoring System; CSS
SF-8


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

85 years-old >

Gender

Male and Female

Key inclusion criteria

Outpatients treated with chronic constipation

Key exclusion criteria

1.Patients with organic constipation(rectal intussusception,rectal prolapse and megacolon)
2.Patients with secondary constipation due to metabolic/endocrine disorders neuromuscular disorders and medication(opioids,antipsychotics,anticholinergic etc)
3.Patients with active intra-abdominal and pelvic malignancy
4.Patients with a history of intestinal resection excluding appendicectomy
5.Patients with active intestinal organic disease(inflammatory bowel disease,diverticular disease etc)
6.Patients with pregnant, possibly pregnant, and lactating subjects are excluded
7.Patients who are considered to be unsuitable by the trial investigator

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Eiji
Middle name
Last name Yamada

Organization

National Hospital Organization Yokohama Medical Center

Division name

Gastroenterology

Zip code

245-8575

Address

3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa

TEL

0458512621

Email

eiji@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name Eiji
Middle name
Last name Yamada

Organization

National Hospital Organization Yokohama Medical Center

Division name

Gastroenterology

Zip code

245-8575

Address

3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa

TEL

0458512621

Homepage URL


Email

eiji@yokohama-cu.ac.jp


Sponsor or person

Institute

National Hospital Organization Yokohama Medical Center

Institute

Department

Personal name



Funding Source

Organization

National Hospital Organization Yokohama Medical Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Hospital Organization Yokohama Medical Center

Address

3-60-2, Harajyuku, Totsuka-ku, Yokohama-shi, Kanagawa

Tel

0458512621

Email

eiji@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 03 Month 20 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

2018 Year 01 Month 20 Day

Date of IRB

2018 Year 03 Month 01 Day

Anticipated trial start date

2018 Year 03 Month 18 Day

Last follow-up date

2020 Year 09 Month 01 Day

Date of closure to data entry

2020 Year 09 Month 15 Day

Date trial data considered complete

2020 Year 09 Month 15 Day

Date analysis concluded

2020 Year 10 Month 15 Day


Other

Other related information

To clarify the clinical significance of evaluating the stool form based on Bristol scale


Management information

Registered date

2018 Year 03 Month 19 Day

Last modified on

2021 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036234


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name