UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036006 |
|---|---|
| Receipt number | R000041012 |
| Scientific Title | Comparison of defecation desire between patients with chronic constipation(CC) and non-constipated people in Japan; A large scale internet survey |
| Date of disclosure of the study information | 2019/02/26 |
| Last modified on | 2019/02/27 08:40:47 |
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Basic information
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
Condition
chronic constipation(CC)
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
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
| 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
Research contact person
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
ohkuboh@yokohama-cu.ac.jp
Public contact
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
nakajima-tky@umin.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Mochida Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Rakuten Insight, Inc
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 02 | Month | 26 | 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
| 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
Other related information
Subjects registered in the large scale online pannel owned by Rakuten Insight, Inc. will be asked to answer the internet questionnaire.
Management information
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
