UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040157
Receipt number 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 18:51:04

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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 or person

Institute

Nara Medical University Gastroenterology

Institute

Department

Personal name



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

Value
https://center6.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