UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053633 |
|---|---|
| Receipt number | R000061213 |
| Scientific Title | Efficacy and Safety of Elobixibat in Home Care Patients with Chronic Constipation A Multicenter Prospective Observational Study |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/02/21 09:24:16 |
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Basic information
Public title
Efficacy and Safety of Elobixibat in Home Care Patients with Chronic Constipation A Multicenter Prospective Observational Study
Acronym
Efficacy and Safety of Elobixibat in Home Care Patients with Chronic Constipation A Multicenter Prospective Observational Study
Scientific Title
Efficacy and Safety of Elobixibat in Home Care Patients with Chronic Constipation A Multicenter Prospective Observational Study
Scientific Title:Acronym
Efficacy and Safety of Elobixibat in Home Care Patients with Chronic Constipation A Multicenter Prospective Observational Study
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observe the efficacy and safety of the study subjects for the first 4 weeks of taking elobixibat.
Basic objectives2
Others
Basic objectives -Others
Investigate the caregivers' burden of defecation management, assessment the changes before and after taking elobixibat.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of normal defecation in the 2nd week of elobixibat in the patients can go to the toilet on their own.
Key secondary outcomes
Proportion of normal defecation in the 4th week of elobixibat in the patients can go to the toilet on their own.
Proportion of normal defecation in the 2nd and 4th week of elobixibat in the patients can't go to the toilet on their own.
The following items in all patient population.
Proportion of normal defecation in the 2nd and 4th weeks of the drug administration period.
Comparison of the number of bowel movements before taking the drug and at the 2nd, 4th weeks of the drug period.
Comparison of degree of straining before taking the drug and at the 2nd, 4th weeks of the drug period.
Comparison of the degree of bowel movement before taking the drug and at the 2nd, the 4th weeks of the drug period.
Comparison of the degree of abdominal distension before taking the drug and at the 2nd, the 4th weeks of the drug period.
Comparison of satisfaction with bowel movements before and at the 2nd, the 4th weeks of the drug period.
Hours from taking elobixibat to defecation at the 2nd , 4th weeks of the drug period.
Comparison of the number of performed enemas before taking the drug and at the 2nd ,4th weeks of the drug period.
Comparison of the number of performed stool extraction before taking the drug and at the 2nd ,4th weeks of the drug period.
Usage of concomitant constipation medications
Sub-analysis by patient background and usage status of elobixibat.
Comparison of the burden of caregiver defecation management before taking the drug and at the 4th week of the administration period.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic constipation
1. Over 20 years Male and female. (obtaining informed consent)
2. Home care patients. (at home)
3. Patients diagnosed with chronic constipation.
4. Patients who have decided to be prescribed elobixibat. (10mg, qd, ac)
5. Patients with hard stools* in the last 1 week.
* The hard stools corresponded to Bristol Stool Form Scale 1 or 2.
6. Patients who have given written informed consent to participation in this research.
Caregivers
1. Over 20 years Male and female. (obtaining informed consent)
2. Caregivers who live with the patients of the study subjects and take care for defecation.
3. Caregivers who have given written informed consent to participate in this research.
Key exclusion criteria
Patients with chronic constipation
1. Patients with a history of hypersensitivity to elobixibat.
2. Patients with confirmed or suspected intestinal obstruction due to tumors, hernias, etc.
3. Patients suspected of constipation due to organic diseases.
4. Patients who have taken the drug of elobixibat within the past 4 weeks.
5. Patients with serious renal disease, liver disease, or heart disease.
6. Other, patients who are judged by a physician to be ineligible to participate in this research, such as a threat to the safety of the research subject or difficulty in complying with the research protocol.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Tsukinaga |
Organization
Satsuki home clinic
Division name
administrative director
Zip code
320-0843
Address
Hanazonomachi 17-1, Utsunomiya-city, Tochigi
TEL
028-688-0456
y.tsukinaga@satsuki-hc.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Satsuki home clinic
Division name
pharmaceutical department
Zip code
320-0843
Address
Hanazonomachi 17-1, Utsunomiya-city, Tochigi
TEL
028-688-0456
Homepage URL
t2.yamamoto@satsuki-hc.com
Sponsor or person
Institute
Satsuki home clinic
Institute
Department
Personal name
Yosuke Tsukinaga
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
Ethics Committee, Yoyogi Mental Clinic
Address
Sendagaya 4-26-11 3F, Shibuya-ku, Tokyo, JAPAN
Tel
03-6804-2227
cns_jimu@triad-j.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
さつきホームクリニック
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NO
Management information
Registered date
| 2024 | Year | 02 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061213
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| Registered date | File name |
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