UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029127
Receipt No. R000033306
Scientific Title The trial for effect of RFX on hepatic encepalopathy
Date of disclosure of the study information 2017/09/13
Last modified on 2019/03/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The trial for effect of RFX on hepatic encepalopathy
Acronym The study of the effect of RFX
Scientific Title The trial for effect of RFX on hepatic encepalopathy
Scientific Title:Acronym The study of the effect of RFX
Region
Japan

Condition
Condition hepatic encephalopathy
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We investigate the effect of RFX on HE
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Improvment of HE
2.Improvment of the intestinal becterial flora
Key secondary outcomes

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)>20 years old
2)The patients obtained the consent
3)>4 weeks of suvival periods
4)AST and ALT > 6 times from the facilities standards
Key exclusion criteria 1)The impossible of oral intake
2)The pharmacokinetics in changed for patient's condition
3)The necessary medicine change the pharmacokinetics of rifaximin
4)The pregnancy and lactaing
5)The allergy of rifaximin
6)The outcome evaluation is difficult for patient's condition
7)The execution plan of achievement is difficult
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Hiroaki
Organization Nara medical unversity
Division name 3rd department of interanal medicine
Zip code 6348521
Address 840,Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Email htky@naramed-u.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Hiroaki Takaya
Organization Nara medical unversity
Division name 3rd department of interanal medicine
Zip code 6348521
Address 840,Shijo-cho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email htky@naramed-u.ac.jp

Sponsor
Institute Nara medical University
Institute
Department

Funding Source
Organization self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nara medical university
Address 840,Shijo-cho, Kashihara, Nara
Tel 0744223051
Email htky@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
2017 Year 09 Month 13 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 Enrolling by invitation
Date of protocol fixation
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing

Management information
Registered date
2017 Year 09 Month 13 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033306

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.