UMIN-CTR Clinical Trial

Public title

Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey

Acronym

Defecation desire in patients with chronic constipation(CC) in Japan; An internet survey

Scientific Title

Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey

Scientific Title:Acronym

Defecation desire in patients with chronic constipation(CC) in Japan; An internet survey

Region

Japan

Condition

chronic constipation(CC)

Classification by specialty

Medicine in general	Gastroenterology	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

)To investigate whether a defecation desire is more reduced in patients with CC who meet Rome-IV criteria than non-constipated people.
2)To elucidate the actual situation of post-treatment symptoms in CC patients taking prescribed medication.

Basic objectives2

Others

Basic objectives -Others

Survey on actual situation

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Defecation desire score in the CC group who meet Rome-IV criteria and non-CC group with age and gender matching

Key secondary outcomes

For all subjects under no treatment situation,
1)Bristol stool form scale
2)Frequency of bowel movement
3)Frequency of difficulty in defecation
4)Frequency of incomplete evacuation
5)Frequency of abdominal pain
6)Time required for evacuation
7)Manual maneuvers to facilitate defecation
8)Number of times of no defecation even if going to the bathroom per 24 hours
9)Disease duration
10)Abdominal pain during defecation
11)Abdominal bloating during defecation
12)Rome-IV criteria
13)Presence or absence of medication for constipation

For patients with CC meeting Rome-IV criteria and taking prescribed medication,
1)Type of drugs used in last one week
2)Disease duration
3)Reason for visit a hospital/clinic
4)Duration of using the over-the-counter drugs before visiting a hospital/clinic
5)Bristol stool form scale in last one week
6)Frequency of defecation desire in last one week
7)Frequency of bowel movement in last one week
8)Frequency of difficulty in defecation in last one week
9)Frequency of incomplete evacuation in last one week
10)Frequency of abdominal pain in last one week
11)Time required for evacuation in last one week
12)Manual maneuvers to facilitate defecation in last one week
13)Number of times of no defecation even if going to the bathroom per 24 hours in last one week
14)Satisfaction for the using drugs in last one week

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Japanese monitor registered in the online panel owned by Rakuten Insight
2) Subjects aged >= 20 years old and <80 years old

Key exclusion criteria

1)Subjects engaged in pharmaceuticals and medical devices industry
2)Subjects engaged in advertisement and broadcasting industry
3)Subjects engaged in research and consulting industry

Target sample size

24000

Name of lead principal investigator

1st name
Middle name
Last name	Hidenori Ohkubo

Organization

Yokohama City University

Division name

Hepatology and Gastroenterology Division

Zip code

Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Email

ohkuboh@yokohama-cu.ac.jp

Name of contact person

1st name
Middle name
Last name	Atsushi Nakajima

Organization

Yokohama City University

Division name

Hepatology and Gastroenterology Division

Zip code

Address

3-9 Fukuura Kanazawa-ku Yokohama City

TEL

045-787-2640

Homepage URL

Email

nakajima-tky@umin.ac.jp

Institute

Yokohama City University

Institute

Department

Personal name

Organization

Mochida Pharmaceutical Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Rakuten Insight, Inc

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

02

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2019

Year

02

Month

01

Day

Date of IRB

Anticipated trial start date

2019

Year

02

Month

27

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Subjects registered in the large scale online pannel owned by Rakuten Insight, Inc. will be asked to answer the internet questionnaire.

Registered date

2019

Year

02

Month

25

Day

Last modified on

2019

Year

02

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041012