UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042139 |
|---|---|
| Receipt number | R000047955 |
| Scientific Title | Efficacy and safety of elobixibat in psychiatric disorders patients with chronic constipation -Retrospective observation research- |
| Date of disclosure of the study information | 2020/10/16 |
| Last modified on | 2022/01/28 11:00:01 |
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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
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
goofice_retro@mebix.co.jp
Sponsor or person
Institute
Nagisa clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047955
