UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039833 |
|---|---|
| Receipt number | R000045433 |
| Scientific Title | Effect of erobixibat on liver dysfunction in patients with chronic constipation |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2021/03/17 23:59:13 |
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Basic information
Public title
Effect of erobixibat on liver dysfunction in patients with chronic constipation
Acronym
Effect of erobixibat on liver dysfunction in patients with chronic constipation
Scientific Title
Effect of erobixibat on liver dysfunction in patients with chronic constipation
Scientific Title:Acronym
Effect of erobixibat on liver dysfunction in patients with chronic constipation
Region
| Japan |
Condition
Condition
Liver dysfunciton
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Improvement effect of liver dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of biochemical parameter (AST, ALT, Alb, Tbil and PT) after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elobixibat 10mg 6months
Interventions/Control_2
Magnesium oxide 2g 6months
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
New patients with chronic constipation
Informed consent
Oral intake
PS 0-2
Key exclusion criteria
Cancer patients
Child pugh grade C
Obstructive jaundice
Severe renal impairment or dialysis
pregnancy
Infection
Mental illness
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhide |
| Middle name | |
| Last name | Higuchi |
Organization
Osaka Medical College
Division name
2nd department of internal medicine
Zip code
5698686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
higuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Asai |
Organization
Osaka Medical College
Division name
2nd department of internal medicine
Zip code
5698686
Address
2-7, Daigakumachi, Takatsuki, Osaka, Japan
TEL
0726831221
Homepage URL
in2108@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical College
Address
2nd department of internal medicine
Tel
0726831221
in2108@osaka-med.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 01 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045433
