UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063310 |
|---|---|
| Receipt number | R000072402 |
| Scientific Title | Constipation Management Insights and Trend |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 12:30:29 |
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Basic information
Public title
Constipation Management Insights and Trend
Acronym
COMMIT study
Scientific Title
Constipation Management Insights and Trend
Scientific Title:Acronym
COMMIT study
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Medicine in general | Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate temporal changes in the use of medications for constipation treatment in Japan and to investigate whether outcomes of constipation management, including the proportion of stimulant laxative use, enema utilization rates, and manual disimpaction rates, have changed over time.
Basic objectives2
Others
Basic objectives -Others
To evaluate temporal trends in constipation medication use and changes in outcomes, including enema administration and manual disimpaction, using a large-scale claims database.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual utilization rates of constipation medications
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
Patients with a diagnosis of constipation recorded in the JMDC (Japan Medical Data Center) health insurance claims database between 2005 and 2025.
Key exclusion criteria
None
Target sample size
800000
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Takatsuki |
Organization
EA Pharma Co.,Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
104-0042
Address
2-1-1, Irifune, Chuo-ku, Tokyo Japan
TEL
08043536796
toshiki_takatsuki@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Takatsuki |
Organization
EA Pharma Co.,Ltd.
Division name
Medical Science Group, Medical Dept.
Zip code
1040042
Address
2-1-1, Irifune, Chuo-ku, Tokyo Japan
TEL
08043536796
Homepage URL
toshiki_takatsuki@eapharma.co.jp
Sponsor or person
Institute
EA Pharma Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
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
Yamauchi Clinic Research Ethics Committee
Address
1-15-9 Jiyugaoka, Meguro-ku, Tokyo, Jaoan
Tel
03-6777-1490
c-irb_ug@neues.co.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
| 2026 | Year | 10 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2026 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072402
