UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050080 |
|---|---|
| Receipt number | R000057053 |
| Scientific Title | A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2023/03/03 09:39:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
Acronym
Elobixibat for Chronic Constipation Without Defecation Desire
Scientific Title
A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation
Scientific Title:Acronym
Elobixibat for Chronic Constipation Without Defecation Desire
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the rate of improvement of defecation desire and symptoms in patients with chronic constipation after 4 weeks of treatment with elobixibat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of change in loss of defecation desire
Key secondary outcomes
Changes in the following items during each week of the treatment period and comparison of the fourth week of the treatment period with the second week of the observation period
1 Presence of defecation desire
2 Satisfaction with defecation desire
3 Satisfaction of straining
4 Degree of straining
5 Presence of a sense of incomplete evacuation
6 Satisfaction with treatment
7 Spontaneous bowel movement (SBM) frequency
8 Complete Spontaneous Bowel Movement (CSBM) frequency
9 Stool hardness based on the Bristol Stool Form Scale
Comparison of Week 4 of the treatment period with Week 2 of the observation period
1 Constipation severity score (CSS)
2 Japanese version of the Patient Assessment of Constipation Quality of Life
3 Change of bile acid cocentration
Change in defecation time.
Examine the relevance among the evaluation items
To examine the relationship among endpoints such as improvement in defecation desire, patient satisfaction, and bile acid levels.
Safety assessment
Incidence rate of diseases
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elobixibat
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
Inclusion Criteria
At the time of provisional registration
Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
Age 20 years or older (at the time of obtaining consent)
Gender Any
outpatients
Patients for whom written consent can be obtained
Patients who can record defecation, etc. in the patient diary
At the time of registration Dosing start criteria
Patients with the following
Loss of defecation desire in the second week of the observation period (1 week before the start of the treatment period)
Loss of defecation desire refers to patients whose presence or absence of defecation desire on the patient questionnaire was 4. almost never or 5. never.
Key exclusion criteria
Exclusion Criteria:
At the time of temporary registration
Exclude patients with any of the following conditions
Patients with organ-related constipation or suspected of having organ-related constipation
Patients with or suspected of having functional ileus
Patients with or suspected of having inguinal hernia
Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
Patients with complications of malignancy
However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
Patients with serious renal, hepatic, or cardiac disease
Patients with drug allergy to the study drug
Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent
However, observational studies are excluded.
Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.
At the time of registration: Dosing start criteria
Patients who increased the dose of concomitantly restricted drugs during the observation period
Patients who used concomitantly prohibited drugs during the observation period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476-35-5600
kessoku-tho@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takaomi |
| Middle name | |
| Last name | Kessoku |
Organization
International university health and welfare Narita hospital
Division name
Palliative medicine and Gastroenterology
Zip code
286-8520
Address
852, Hatakeda, Narita, Chiba, Japan
TEL
0476-35-5600
Homepage URL
kessoku-tho@umin.ac.jp
Sponsor or person
Institute
International university health and welfare Narita hospital
Institute
Department
Personal name
Funding Source
Organization
Self
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
International university health and welfare Narita hospital
Address
852, Hatakeda, Narita, Chiba
Tel
0476-35-5600
kessoku-tho@umin.ac.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
| 2023 | Year | 01 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057053
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
