UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056635 |
|---|---|
| Receipt number | R000064627 |
| Scientific Title | Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/01/23 18:21:12 |
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Basic information
Public title
Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation
Acronym
Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation
Scientific Title
Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation
Scientific Title:Acronym
Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of elobixibat administration in patients with chronic constipation diagnosed by rectal ultrasonography. In addition, the study will explore the relationship between the transverse diameter of the colon and rectum and the efficacy of elobixibat, as well as the relationship between the transverse diameter of the colon and rectum and rectal ultrasonographic classifications.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat in patients with chronic constipation diagnosed by rectal ultrasonography as "no stool accumulation"
* Responders are those who have at least one or more bowel movements during the study period without the use of suppositories for bowel movement (bisacodyl suppositories, etc.)/ enema or disimpaction
Key secondary outcomes
1. Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat in patients with chronic constipation diagnosed by rectal ultrasonography as "stool accumulation with hard stools" and "stool accumulation without hard stools"
2. Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat, regardless of rectal ultrasonographic classification
3. Percentage of responders* with spontaneous bowel movement on day 1 after the initial administration of elobixibat, categorized by rectal ultrasonographic classifications
4. Percentage of responders* with spontaneous bowel movement on day 1 after the initial administration of elobixibat, regardless of rectal ultrasonographic classification
5. Comparison of BSFS before and after the administration of elobixibat
6. Comparison of CSS before and after the administration of elobixibat
7. Comparison of CSS sub scores before and after the administration of elobixibat
8. Relationship between the transverse diameter of the colon and rectum and rectal ultrasonographic classifications, and relationship between the transverse diameter of the colon and rectum and the efficacy of elobixibat
9. Subgroup analysis by background factors for primary and secondary endpoints
10. Items and incidence rates of adverse events and adverse reactions
11. Discontinuation rate
* Responders are those who have at least one or more bowel movements during the study period without the use of suppositories for bowel movement (bisacodyl suppositories, etc.)/ enema or disimpaction
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 18 years of age or older
2. Patients who were judged by a doctor to be inadequate for treatment with existing therapies alone in terms of efficacy and safety.
3. Patients who received elobixibat according to the dosage and administration during the study period (concomitant use with other laxatives allowed)
4. Patients who underwent rectal ultrasonography on the day before the initial administration of elobixibat
Key exclusion criteria
1. Patients with a history of hypersensitivity to elobixibat at the time of the initial administration of elobixibat
2. Patients with confirmed or suspected bowel obstruction due to tumors, hernias, or other causes at the time of the initial administration of elobixibat
3. Patients with suspected constipation due to organic disease at the time of the initial administration of elobixibat
4. Patients who used bowel cleansing agents, enemas, or underwent intestinal lavage within the 2 days before and up to 3 days after the rectal ultrasonography.
5. Patients who participated in clinical trials or interventional studies during the observation period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Norishige |
| Middle name | |
| Last name | Maiya |
Organization
NHO Hakodate Medical Center
Division name
Department of Gastroenterology
Zip code
041-8512
Address
18-16, Kawaharacho, Hakodate Shi, Hokkaido
TEL
0138-51-6281
momoko0221tsuda@gmail.com
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Watanabe |
Organization
SRD Co., Ltd.
Division name
Clinical Research Department
Zip code
104-0032
Address
3-4-8, Hatchobori, Chuo-ku, Tokyo
TEL
03-5543-0302
Homepage URL
gof.us-echo@cro-srd.co.jp
Sponsor or person
Institute
NHO Hakodate Medical Center
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido Cancer Society
Name of secondary funder(s)
Mochida Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Ethics Committee of National Hospital Organization Hakodate Medical Center
Address
18-16, Kawaharacho, Hakodate Shi, Hokkaido
Tel
0138-51-6281
demura.mamiko.ex@mail.hosp.go.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
独立行政法人 国立病院機構 函館医療センター（北海道）、公益財団法人北海道対がん協会札幌がん検診センター（北海道）/NHO Hakodate Medical Center (Hokkaido), Hokkaido Cancer Society (Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.mdpi.com/2075-4418/16/2/354
Number of participants that the trial has enrolled
32
Results
Among 18 patients in the "no fecal retention" group, 94.4% achieved SBMs within 3 days, indicating a favorable short-term response. Adverse events included abdominal distension and abdominal pain, each observed in one patient (3.1%).
Results date posted
| 2026 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 01 | Month | 21 | Day |
Baseline Characteristics
In the efficacy analysis set, there were 6 males (19.4%) and 25 females (80.6%), and in the safety analysis set, there were 6 males (18.8%) and 26 females (81.3%). The mean age was 56.8 years in the efficacy set and 56.5 years in the safety set. Baseline bowel movement data (median) for the efficacy and safety sets, respectively, were as follows: BSFS score, 1.0 and 1.0; CSS total score, 13.5 and 13.5; and modified CSS total score, 10.0 and 10.0. CSS sub-scores were as follows: frequency of bowel movements, 1.0 and 1.0; painful evacuation effort, 2.0 and 2.0; feeling of incomplete evacuation, 3.0 and 3.0; abdominal pain, 1.0 and 1.0; minutes in lavatory per attempt, 1.0 and 1.0; type of assistance, 1.0 and 1.0; unsuccessful evacuation attempts per 24 hours, 1.0 and 1.0; and duration of constipation, 3.0 and 3.0.
Participant flow
During the study period, 249 patients underwent rectal US, and 110 were prescribed elobixibat after the procedure. Among them, 32 patients met the eligibility criteria and were enrolled in the study. All 32 patients were included in the safety analysis set. One patient with a colostomy was excluded from the efficacy analysis set, leaving 31 patients for efficacy evaluation. Based on rectal US findings, 18 patients were classified as "no fecal retention," 1 as "fecal retention without hard stools," 2 as "fecal retention with hard stools," and 8 as "gas retention." Rectal US findings could not be visualized in two patients.
Adverse events
Adverse events occurred in two patients (6.3%) in the safety analysis set. All events were mild and resolved without intervention. No serious adverse events occurred, and no patients discontinued elobixibat during the 2-week observation period.
Outcome measures
Among 18 patients in the "no fecal retention" group, 94.4% achieved SBMs within 3 days after elobixibat administration, and among 8 patients in the "gas retention" group, 100.0% achieved SBMs, indicating a favorable response. Adverse events included abdominal distension and abdominal pain, each observed in one patient (3.1%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 14 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 14 | Day |
Date trial data considered complete
| 2025 | Year | 04 | Month | 21 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 11 | Day |
Other
Other related information
Study design: observational study
Observation period: May 1, 2019 - December 3, 2024
Subjects will be patients with chronic constipation who underwent rectal ultrasonography and received elobixibat at the study site during the study period. The efficacy and safety of elobixibat will be evaluated using observational and examination items obtained from medical records and patient questionnaires. In addition, the relationship between the transverse diameter of the colon and rectum and the efficacy of elobixibat, as well as the relationship between the transverse diameter of the colon and rectum and rectal ultrasonographic classifications, will be explored.
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064627
