UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation -Retrospective observation research-
Acronym	Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation
Scientific Title	Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation -Retrospective observation research-
Scientific Title:Acronym	Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation
Region	Japan

Condition
Condition	Psychiatric disorders patients with chronic constipation
Classification by specialty	Gastroenterology Psychosomatic Internal Medicine Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the stool frequency before and after 4 weeks of treatment by elobixibat
Key secondary outcomes	- Comparison of the stool frequency before and after 8, 12, 24, and 52 weeks of treatment by elobixibat - Use of concomitant drugs for constipation - Sub-analysis by the patients' background and the treatment status of elobixibat - Incidence rate and item of adverse events and adverse drug reaction - Discontinuation rate of elobixibat

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	1. Patients with 20 years or older 2. Patients diagnosed with chronic constipation who had less than 3 defecation per week prior to administration of elobixibat 3. Outpatients diagnosed with depression, schizophrenia, bipolar disorder and anxiety disorder 4. Patients who were administrated elobixibat for at least 4 weeks continuously from July 1, 2018 to June 30, 2020 (Concomitant use of other drugs for the treatment of constipation should be allowed)
Key exclusion criteria	1. Patients with a history of hypersensitivity to elobixibat 2. Patients with confirmed or suspected bowel obstruction due to a tumor or hernia 3. Patients with suspected constipation due to organic disease 4. Patients diagnosed with dementia 5. Patients who have been determined by a physician to be inappropriate to administrate elobixibat
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masashi Middle name Last name Sasa
Organization	Nagisa clinic
Division name	Director of the clinic
Zip code	573-1183
Address	24-31 Nagisaminamimachi, Hirakata-shi, Osaka, Japan
TEL	072-848-1212
Email	goofice_retro@mebix.co.jp

Public contact
Name of contact person	1st name Masashi Middle name Last name Sasa
Organization	Nagisa clinic
Division name	Director of the clinic
Zip code	573-1183
Address	24-31 Nagisaminamimachi, Hirakata-shi, Osaka, Japan
TEL	072-848-1212
Homepage URL
Email	goofice_retro@mebix.co.jp

Sponsor
Institute	Nagisa clinic
Institute
Department

Funding Source
Organization	MOCHIDA PHARMACEUTICAL CO., LTD., 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)

IRB Contact (For public release)
Organization	Medical Corporation Rikeikai, Yamanouchi Clinic Ethics Committee
Address	1-15-19 Jiyugaoka, Meguro-ku, Tokyo, Japan
Tel	03-5575-5862
Email	c-irb_ug@neues.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	渚クリニック（大阪府）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 16 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	28
Results	This study was a retrospective study on effectiveness and safety of elobixibat for chronic constipation in 28 psychiatric outpatients such as depression and schizophrenia. There was a significant increase in frequency of bowel movements per week, 4 and 52 weeks after treatment with elobixibat compared to that before the treatment. In addition, adverse events were observed in 3 patients, although those were not serious including mild diarrhea. (The Japanese Journal of Psychiatry. 2021; 26(6): 553-560)
Results date posted	2021 Year 11 Month 26 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 11 Month 25 Day
Baseline Characteristics	Among the 28 patients enrolled, 18 (64.3%) were female, and the mean age was 62.3 +- 14.6 (SD) years. Psychiatric disorders included depression (21 patients: 75.0%), schizophrenia (4 patients: 14.3%), bipolar disorder (2 patients: 7.1%), and anxiety disorder (1 patient: 3.6%).
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2020 Year 09 Month 07 Day
Date of IRB	2020 Year 10 Month 15 Day
Anticipated trial start date	2020 Year 10 Month 16 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The effectiveness and safety of elobixibat will be evaluated by obtaining observations and laboratory tests from the medical records of the subjects who received elobixibat at the clinic during the study period. The observation period will be from before the start of elobixibat administration to a maximum of 52 weeks after the start of treatment. Information on patient background, number of defecation, elobixibat administration, concomitant drugs, and adverse events will be collected retrospectively.

Management information
Registered date	2020 Year 10 Month 16 Day
Last modified on	2022 Year 01 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047955