UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062789 |
|---|---|
| Receipt number | R000071537 |
| Scientific Title | A retrospective observational study on the efficacy and safety of elobixibat in patients with schizophrenia and chronic constipation. |
| Date of disclosure of the study information | 2026/09/02 |
| Last modified on | 2026/09/02 18:33:56 |
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Basic information
Public title
A retrospective observational study on the efficacy and safety of elobixibat in patients with schizophrenia and chronic constipation.
Acronym
EXB-Okehazama-SZ
Scientific Title
A retrospective observational study on the efficacy and safety of elobixibat in patients with schizophrenia and chronic constipation.
Scientific Title:Acronym
EXB-Okehazama-SZ
Region
| Japan |
Condition
Condition
Schizophrenia and Chronic Constipation
Classification by specialty
| Gastroenterology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the efficacy and safety of elobixibat in patients with schizophrenia who have chronic constipation. In addition, the relationship between bowel movement frequency and psychiatric symptoms will be explored in an exploratory manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the weekly number of bowel movements between 1 week before the initiation of elobixibat and 2 weeks after its initiation
Key secondary outcomes
-Changes in the weekly number of bowel movements during the observation period
-Changes in the frequency of enema administration during the observation period
-Changes in the frequency of manual fecal disimpaction during the observation period
-Changes in the frequency of as-needed laxative administration during the observation period
-Proportion of patients who required bowel management procedures or received as-needed laxatives
-Subgroup analyses stratified by patient characteristics, elobixibat treatment status, and concomitant medications (based on the number of concomitantly used antipsychotics or anticholinergic burden)
-Relationship between bowel movement frequency and PANSS scores during the observation period
-Relationship between bowel movement frequency and BE PSD scores during the observation period
-Types and incidence of adverse events and adverse drug reactions
-Discontinuation rate
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
Male or female patients aged 18 years or older
Patients diagnosed with chronic constipation
Patients diagnosed with schizophrenia
Patients who were hospitalized at this institution from 1 week prior to the initiation of elobixibat to 2 weeks after the start of treatment
Patients who received elobixibat for at least 2 weeks and had available bowel movement frequency data
Patients who were first administered elobixibat in accordance with the approved dosage and administration between April 19, 2018, and June 16, 2026
Key exclusion criteria
Patients who were prescribed any constipation medication during the observation period* in a manner that deviated from the approved dosage and administration
Patients with a history of hypersensitivity to at the initiation of treatment
Patients in whom intestinal obstruction (e.g., due to tumors or hernia) has been confirmed or is suspected at the initiation of elobixibat treatment
Patients in whom constipation due to an organic disease is suspected at the initiation of elobixibat treatment
*The period from the observation at the start of administration[TO1.1][TS1.2] to the final observation
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mekata |
Organization
Fujita Kokoro Care Center, Okehazama Hospital
Division name
Vice Director
Zip code
470-1168
Address
3-879,Minamiyakata,Sakae-cho,Toyoake,Aichi
TEL
0562-97-1361
Mekata-slack@seishinkai-kokoro.jp
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Mandokoro |
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
exb_O_sz@cro-srd.co.jp
Sponsor or person
Institute
Fujita Kokoro Care Center, Okehazama Hospital
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
Name of secondary funder(s)
Mochida Pharmaceutical Co., Ltd.
IRB Contact (For public release)
Organization
Fujita Kokoro Care Center IRB
Address
3-879,Minamiyakata,Sakae-cho,Toyoake,Aichi
Tel
0532-96-1361
crc-tsuboi.so@seishinkai-kokoro.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
桶狭間病院藤田こころケアセンター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 02 | 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
200
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study.
Observation period: April 19, 2018 - June 30, 2026.
Study subjects:Patients with schizophrenia and chronic constipation who were first administered elobixibat in accordance with the approved dosage and administration between April 19, 2018, and June 16, 2026, and met the eligibility criteria.
Management information
Registered date
| 2026 | Year | 09 | Month | 02 | Day |
Last modified on
| 2026 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071537
