UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054953 |
|---|---|
| Receipt number | R000062783 |
| Scientific Title | Investigation of the Economic Burden of Constipation in Patients With Chronic Musculoskeletal Pain |
| Date of disclosure of the study information | 2024/07/12 |
| Last modified on | 2026/01/13 17:48:43 |
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Basic information
Public title
Investigation of the Economic Burden of Constipation in Patients With Chronic Musculoskeletal Pain
Acronym
Investigation of the Economic Burden of Constipation in Patients With Chronic Musculoskeletal Pain
Scientific Title
Investigation of the Economic Burden of Constipation in Patients With Chronic Musculoskeletal Pain
Scientific Title:Acronym
Investigation of the Economic Burden of Constipation in Patients With Chronic Musculoskeletal Pain
Region
| Japan |
Condition
Condition
Constipation
Classification by specialty
| Gastroenterology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the economic value of relieving constipation and alleviating patient burden caused by constipation in patients with chronic musculoskeletal pain who visit orthopedics, anesthesiology, or pain clinics.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The economic value of relieving constipation symptoms in patients with constipation
Key secondary outcomes
Bowel movement and constipation symptoms based on the use of opioid analgesics
Impact of constipation on patients' daily life
Impact of constipation on patients' work productivity
Impact of constipation on pain treatment in patients
Measures for managing constipation symptoms in patients
Frequency of outpatient visits to obtain constipation medication for patients
Economic burden of constipation symptoms in patients
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients registered in the subject panel
Patients with chronic musculoskeletal pain
Patients visiting orthopedics, anesthesiology, or pain clinics
Patients capable of responding to questions through internet-connected devices such as computers or smartphones
Patients who have consented to participate in this study and provided electronic consent
Key exclusion criteria
Patients who are either patients themselves or have family members living with them, working in the healthcare or welfare-related industry, surveying, advertising, or marketing industry
Patients whose primary residence and lifestyle are conducted outside of Japan
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kinoshita |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
5410045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka
TEL
08024670790
masahiro.kinoshita@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kurazono |
Organization
Shionogi & Co., Ltd.
Division name
Medical Affairs
Zip code
5410045
Address
1-8, Dosho-machi 3-chome, Chuo-ku, Osaka
TEL
08053647605
Homepage URL
kenji.kurazono@shionogi.co.jp
Sponsor or person
Institute
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science
Address
12th floor, Sumitomo Shibadaimon Building, 2-5-5 Shibadaimon, Minato-ku, Tokyo
Tel
0357335010
rihds@jmdc.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
| 2024 | Year | 07 | Month | 12 | 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
3000
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
Completed
Date of protocol fixation
| 2024 | Year | 03 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 09 | Month | 13 | Day |
Other
Other related information
questionnaire survey(cross-sectional study)
Management information
Registered date
| 2024 | Year | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062783
