UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055903 |
|---|---|
| Receipt number | R000063798 |
| Scientific Title | Analyses of the socio-economic values of treatments for chronic constipation |
| Date of disclosure of the study information | 2024/10/22 |
| Last modified on | 2025/10/22 20:02:13 |
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Basic information
Public title
Analyses of the socio-economic values of treatments for chronic constipation
Acronym
Analyses of the socio-economic values of treatments for chronic constipation
Scientific Title
Analyses of the socio-economic values of treatments for chronic constipation
Scientific Title:Acronym
Analyses of the socio-economic values of treatments for chronic constipation
Region
| Japan |
Condition
Condition
Chronic Constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether there are differences in the cost-effectiveness of new drugs for chronic constipation, considereing a wide range of socio-economic burdens associated with chronic constipation.
Basic objectives2
Others
Basic objectives -Others
Socio-economic evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare socio-economic burdens including treatement costs, productivity loss, and caregiving burden between drugs for chronic constipation
Key secondary outcomes
To assess socio-economic burdens by characteristics of patients with chronic constipation
Base
Study type
Others,meta-analysis etc
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
Not Applicable
Key exclusion criteria
Not Applicable
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Unno |
Organization
EA Pharma Co., Ltd.
Division name
Medical Dept.
Zip code
104-0042
Address
1-1, Irifune 2-chome, Chuo-ku, Tokyo
TEL
03-6280-9631
aki_unno@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Inagaki |
Organization
EA Pharma Co., Ltd.
Division name
Medical Dept.
Zip code
104-0042
Address
1-1, Irifune 2-chome, Chuo-ku, Tokyo
TEL
03-6280-9631
Homepage URL
katsutoshi_inagaki@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
Japan
Other related organizations
Co-sponsor
Healthcare Consulting Inc.
Name of secondary funder(s)
Mochida Pharmaceutical Plant Co., Ltd.
IRB Contact (For public release)
Organization
Not Applicable
Address
Not Applicable
Tel
Not Applicable
Not Applicable
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
| 2024 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04334-8
Number of participants that the trial has enrolled
0
Results
Patients treated with elobixibat showed lower total costs and better QoL than those treated with linaclotide and lubiprostone. The deterministic sensitivity analysis showed that the base-case results were generally robust to changes in most input parameters but were sensitive to the effectiveness of elobixibat and lubiprostone. The probabilistic sensitivity analysis showed that 72.3% and 64.0% of observations showed better QoL for elobixibat 10 mg.
Results date posted
| 2025 | Year | 10 | Month | 22 | Day |
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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will conduct a systematic review and network meta-analysis of published papers of clinical trial results, and then use the synthesized values to conduct a cost-effectiveness analysis through simulation. Therefore, this study is not subject to ethical review.
Management information
Registered date
| 2024 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063798
