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
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
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
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
