UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051507 |
|---|---|
| Receipt number | R000058763 |
| Scientific Title | A survey of the work productivity outcomes in patients with chronic constipation |
| Date of disclosure of the study information | 2023/07/03 |
| Last modified on | 2025/01/28 20:05:18 |
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Basic information
Public title
A survey of the work productivity outcomes in patients with chronic constipation
Acronym
A survey of the work productivity outcomes in patients with chronic constipation
Scientific Title
A survey of the work productivity outcomes in patients with chronic constipation
Scientific Title:Acronym
A survey of the work productivity outcomes in patients with chronic constipation
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore constipation symptoms correlated with loss of work productivity and daily activity decline in patients with chronic constipation.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to explore constipation symptoms correlated with loss of work productivity and daily activity decline in patients with chronic constipation.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Work productivity outcomes (absenteeism, presenteeism, total work productivity impairment, total activity impairment)
2) Correlation between total work productivity impairment and each constipation symptom
3) Correlation between total activity impairment and each constipation symptom
4) Work productivity outcomes (absenteeism, presenteeism, total work productivity impairment, total activity impairment) by the presence of each constipation symptom
5) Correlation between total work productivity impairment and satisfaction with constipation treatment
6) Correlation between total activity impairment and satisfaction with constipation treatment
7) Satisfaction with constipation treatment
8) Correlation between satisfaction with constipation treatment and each constipation symptom
9) Change in the degree of work productivity loss/activity loss from before the start of treatment
10) Subgroup analysis by patient background
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are able to provide informed consent for participation in this study
2) At the time of study participation, the patient is taking or using medication for constipation prescribed by a medical facility for chronic constipation.
Key exclusion criteria
1)Patients who work for any of the following organizations (pharmaceutical or medical devices industry, advertising and broadcasting industry, survey and consulting services industry)
2) aged <18 years
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Takebe |
Organization
Mochida Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
160-8515
Address
1-7 Yotsuya, Shinjuku-ku, Tokyo 160-8515 Japan
TEL
03-3225-5238
takahiro.takebe@mochida.co.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Ota |
Organization
Mochida Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
160-8515
Address
1-7 Yotsuya, Shinjuku-ku, Tokyo 160-8515 Japan
TEL
03-3225-5238
Homepage URL
takumi.ota@mochida.co.jp
Sponsor or person
Institute
Mochida Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mochida Pharmaceutical Co., Ltd.,
EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.com
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
| 2023 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/jgh3.70042
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/jgh3.70042
Number of participants that the trial has enrolled
2351
Results
Among the 2351 analyzed patients (mean age, 51.7 years), 80.7% were females, and 1424 were working.
The annual work productivity loss per patient was estimated to be 1.343 million Yen.
Symptoms that had a statistically significant positive correlation with total work impairment were abdominal discomfort/nausea, abdominal pain, abdominal bloating, and unpredictable defecation timing. Work productivity and daily activity had improved in 71.2% and 72.6% of patients after they received treatment.
Results date posted
| 2025 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 11 | Month | 04 | Day |
Baseline Characteristics
The overall mean age of patients was 51.7+-13.8 years and a majority of them were female (80.7%). The disease duration was 10 years or longer for 63.3% of patients. The mean number of prescribed laxatives was 1.6+-1.0. Of these, the most prescribed laxative was magnesium oxide (70.1%), followed by stimulant laxatives (23.6%) and Chinese herbal medicine (23.4%).
Participant flow
A screening survey was conducted among a total of 187,347 participants. It identified 2,362 patients with chronic constipation meeting the study's eligibility criteria. Subsequently, sample exclusion was carried out in accordance with the predefined data cleaning standards. As a result, six patients were excluded since they had incomprehensible or inappropriate free-text response, and five patients were excluded as they reported too many complications which made the reliability of their responses questionable. Therefore, 2,351 patients were included in the analysis.
Adverse events
Not evaluated.
Outcome measures
The work productivity outcomes included ratio of lost working hours, work impairment ratio and daily activity impairment ratio, correlation between total work impairment ratio or daily activity impairment ratio and each constipation symptom, work productivity outcomes with or without each constipation symptom (ratio of lost work hours, work impairment ratio, daily activity impairment ratio), and changes in degrees of work productivity loss or activity loss from before treatment. Further, the total work productivity loss was calculated by the following formulae: absenteeism, presenteeism, total work productivity loss, activity impairment. Indirect costs were defined as the monetary value of total work productivity loss and calculated by using the estimated overall wages or salaries in Japanese Yen for each patient from the Ministry of Health, Labour, and Welfare.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 04 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 03 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058763
