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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042139
Receipt No. 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 2021/04/06

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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
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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 28
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
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
2021 Year 04 Month 06 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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