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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040157
Receipt No. R000045026
Scientific Title Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone
Date of disclosure of the study information 2020/04/21
Last modified on 2020/04/14

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Basic information
Public title Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone
Acronym Improvement of hepatic encephalopathy and hepatic functional reserve by lubiprostone
Scientific Title Prospective clinical study aiming at the improvement of hepatic encephalopathy and hepatic functional reserve of patients with liver cirrhosis by the secretory laxative agate lubiprostone
Scientific Title:Acronym Improvement of hepatic encephalopathy and hepatic functional reserve by lubiprostone
Region
Japan

Condition
Condition hepatic encephalopathy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We show that lubiprostone safely and effectively promotes defecation and significantly suppresses the onset and exacerbation of hepatic encephalopathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following is the measurement, an item evaluating at point of start, 1, 3, 6 months.
serum NH3
Key secondary outcomes The following is the measurement, an item evaluating at point of start, 1, 3, 6 months.
Blood exams; Blood count, prothrombin time, various blood biochemistry [Alb, AST, ALT, ALP, gamma-GTP, T-Bil, Cre, CRP, NH3], endotoxin-related marker (EAA, CD163, CD206)

Simple inspection: Number connection test, Stroop test, CLD questionnaire
with or without adverse event, stool frequency and status (ever average of 2 weeks), the weight change.

It is an item to evaluate at six months at the point of start as follows.
An examination for feces: An enterobacterial flora change, feces organic acid analysis.
Confirm the following items by ELISA (TNF-alpha, IL-6, IL-12, IL-10, TGF-beta).

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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients with cirrhosis diagnosed with hepatic encephalopathy.
Key exclusion criteria 1. <=19 y.o. or 81 y.o.<=
2. pregnancy or breast-feeding
3. have ever taken lubiprostone
4. heart failure (admission by 6 months)
5. renal severe failure(eGFR<30 ml/min/1.73m2)
6. serum sodium <125mEq/L or >150mEq/L
7. Cerebral infarction without paralysis and lacunar infarction
8. Dementia more than Performance Status 2
9. abdominal surgery career (stomach segmental resection or intestinal tract excision)
10. with taking opioid agents
11. change or increase diuretic agents for obserbation period
12. with infectious disease or gastrointestinal breeding
13. with malignant tumor
14. patients of refusal this trial
15. The patient who judged that this study responsibility doctor and allotment doctor were inadequate
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ogawa
Organization Nara Medical University
Division name Gastroenterology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara-shi, Nara
TEL 0744223051
Email ogawah@naramed-u.ac.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Ogawa
Organization Nara Medical University
Division name Gastroenterology
Zip code 634-8522
Address 840 Shijo-cho, Kashihara-shi, Nara
TEL 0744223051
Homepage URL
Email ogawah@naramed-u.ac.jp

Sponsor
Institute Nara Medical University Gastroenterology
Institute
Department

Funding Source
Organization Nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University
Address 840 Shijo-cho, Kashihara-shi, Nara
Tel 0744223051
Email ogawah@naramed-u.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 21 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 Preinitiation
Date of protocol fixation
2019 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 21 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Obserbational Study

Management information
Registered date
2020 Year 04 Month 14 Day
Last modified on
2020 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045026

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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