UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039688 |
|---|---|
| Receipt number | R000045269 |
| Scientific Title | Internet survey on the actual situation of constipation in the Japanese population |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2023/01/18 12:08:17 |
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Basic information
Public title
Internet survey of constipation in Japan
Acronym
Internet survey on the actual situation of constipation in the Japanese population
Scientific Title
Internet survey on the actual situation of constipation in the Japanese population
Scientific Title:Acronym
Internet survey of constipation in Japan
Region
| Japan |
Condition
Condition
constipation, gastroesophageal reflux disease, functional dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim in this study is to perform an internet survey of constipation. Demographic factors, lifestyle, defecation, and laxatives are investigated.
Basic objectives2
Others
Basic objectives -Others
The frequency of overlap among constipation, functional dyspepsia, and gastroesophageal reflux disease is investigated.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The frequency of overlap among constipation, functional dyspepsia, and gastroesophageal reflux disease.
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
| 20 | years-old | <= |
Age-upper limit
| 69 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women from 20 years old to 69 years old.
Key exclusion criteria
Gastrointestinal carcinoma, inflammatory bowel disease, or a history of abdominal surgery.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Naotaka |
| Middle name | |
| Last name | Ogasawara |
Organization
Aichi Medical University School of Medicine
Division name
Gastroenterology
Zip code
4800-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
nogasa@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Naotaka |
| Middle name | |
| Last name | Ogasawara |
Organization
Aichi Medical University School of Medicine
Division name
Gastroenterology
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi
TEL
0561-62-3311
Homepage URL
nogasa@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University School of Medicine
Address
1-1, Yazakokarimata, Nagakute, Aichi
Tel
056-62-3311
kenshi@aichi-med-u.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
| 2020 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jnmjournal.org/journal/view.html?doi=10.5056/jnm21065
Publication of results
Published
Result
URL related to results and publications
https://www.jnmjournal.org/journal/view.html?doi=10.5056/jnm21065
Number of participants that the trial has enrolled
10000
Results
Among 10 000 survey responses received, functional constipation (Rome IV diagnostic criteria) was reported by 439 participants; chronic constipation (Japanese guidelines) by 3804 participants; and subjective constipation symptoms by 2563 participants. Participants with constipation/GERD overlap had poorer quality of life (P < 0.001) and worse GERD symptom scores (P < 0.001). The frequency of abnormal stools was highest (P < 0.001) in the constipation/GERD overlap group.
Results date posted
| 2023 | Year | 01 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The inclusion criteria required participants to be males or females aged 20 to 69 years (inclusive), who provided informed consent for survey participation.
Exclusion criteria were previous open surgery of the abdomen (excluding appendicitis); intestinal diseases such as inflammatory bowel disease, ulcerative colitis, and Crohn's disease; cancer of the GI tract; pregnancy; and inability to follow the study instructions.
Participant flow
Participants were recruited from panels of the general public held by a survey company (Rakuten Insight Co, Ltd, Osaka, Japan). Inclusion and exclusion criteria were applied, and 10000 individuals meeting the eligibility criteria were enrolled after adjustments to reflect the general Japanese population's prefectural and age composition.
Adverse events
None.
Outcome measures
The primary study endpoint was the frequency of overlap of constipation and GERD. The secondary endpoints for the study were the investigation of background factors affecting constipation and GERD overlap, the examination of the association between constipation and GERD overlap via each disease measure (SF-8, GSRS, CSS, and FSSG), and investigation of the association between background factors and items, including SF-8 score, GSRS score, FSSG score, Bristol stool form scale (BSFS) score, CSS score, satisfaction with bowel movement, treatment with gastric or constipation medication, and type of gastric or constipation medication.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2020 | Year | 03 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 28 | Day |
Other
Other related information
None.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045269
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