UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048352 |
|---|---|
| Receipt number | R000055108 |
| Scientific Title | Survey on prescription of the new laxatives in patients with chronic constipation under daily clinical practice, using real-world data |
| Date of disclosure of the study information | 2022/07/12 |
| Last modified on | 2024/04/17 14:39:40 |
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Basic information
Public title
Survey on prescription of the new laxatives in patients with chronic constipation under daily clinical practice, using real-world data
Acronym
Survey on prescription of the new laxatives in the patients with chronic constipation
Scientific Title
Survey on prescription of the new laxatives in patients with chronic constipation under daily clinical practice, using real-world data
Scientific Title:Acronym
Survey on prescription of the new laxatives in the patients with chronic constipation
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The prescription of the new laxatives in patients with chronic constipation under daily clinical practice will be surveyed.
Basic objectives2
Others
Basic objectives -Others
Another aim of this study are to evaluate the prescription status and to explore the risk factors for discontinuation of the new laxatives (i.e., macrogol 4000 + electrolytes [M4000E] and elobixibat [ELO]). In addition, the prescription changes of other laxatives before and after the initiation of the drugs will be described.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The following outcome will be evaluated for M4000E and ELO independently.
- Drug survival of each drug after the initiation of the medication.
-Risk factors for discontinuation of each drug
-The prescription changes of other laxatives before and after the initiation of each drug.
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
The following patients will be extracted from the RWD database. The cohort will be constructed for each drug, independently. The day of the first prescription of each drug will be defined as the index date.
- Patients who initiate M4000E or ELO from April 1, 2018, to March 31, 2022.
Key exclusion criteria
The patients who have no hospital visits from 180 days to 1 day before the index date.
Target sample size
19000
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | Ishizaki |
Organization
EA Pharma Co., Ltd.
Division name
Medical Science group Medical department
Zip code
104-0042
Address
Sumitomo Irifune building 2-1-1, Irifune, Chuou-ku, Tokyo, Japan
TEL
03-6280-9814
sonoko_ishizaki@eapharma.co.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Shimamoto |
Organization
Real World Data Co., Ltd.
Division name
Research & Analytics
Zip code
604-0086
Address
76 Ogawadori Marutamachi-sagaru Nakanocho, Nakagyo-ku, Kyoto, Japan
TEL
075-748-0742
Homepage URL
shimamoto@rwdata.co.jp
Sponsor or person
Institute
EA Pharma Co., Ltd.
Medical Science group Medical department
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
Mochida Pharmaceutical 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
Sumitomo Shibadaimon building 2-5-5, Shibadaimon, Minato-ku, Tokyo, Japan
Tel
03-5733-5010
rihds@jmdc.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
RI2021027
Org. issuing International ID_1
Research Institute of Healthcare Data Science
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
リアルワールドデータ株式会社 (Real World Data, Co., Ltd.)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0011393X23000334?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0011393X23000334?via%3Dihub
Number of participants that the trial has enrolled
19295
Results
ELO discontinuation (DC) rate within 360 days was 78.7%. Inpatients, end-stage renal failure, and diagnosis of constipation by obstetrics/gynecology or oncology departments were identified as risks for DC. Diagnosis of constipation, diabetes mellitus, Parkinson's disease, or use of laxative (LX) was lower risk of DC. The prescription rate of stimulants and saline LX decreased and nearly half of them discontinued these LX within 360 days.
Results of M4000E were published in JPT 52(3) 253-67 in Japanese.
Results date posted
| 2024 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 11 | Month | 17 | Day |
Baseline Characteristics
ELO
Mean age :73.0 +/- 13.7 years
Male n(%): 5,548(50.2)
Female n(%):5,514(49.8)
In-patient n(%):5,075(45.9)
M4000E
Mean age :55.7 +/- 31.7 years
0-11 years n(%):1,776(21.6)
Male n(%): 3,997(48.5)
Female n(%): 4,236(51.5)
In-patient n(%):3,181(38.6)
Participant flow
Patients prescribed ELO or M4000E from April 1, 2018, to March 31, 2022, were extracted from the database.
In total, 11,062 and 8,233 patients who were prescribed ELO or M4000E were evaluated independently.
Adverse events
Not evaluated
Outcome measures
ELO/M4000E
The discontinuation of ELO/M4000E and stimulant or saline laxatives during ELO/M4000E treatment was evaluated using the Kaplan-Meier method. The Cox proportional hazards model evaluated risk factors associated with laxative discontinuation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 03 | Day |
Date of closure to data entry
| 2022 | Year | 05 | Month | 03 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 08 | Day |
Other
Other related information
This study is retrospective observational study. Therefore, the follow-up periods will be before the day of IRB approved. The data of study population is already extracted from the database. Analyses was ended on Jul 14 2022.
Management information
Registered date
| 2022 | Year | 07 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055108
