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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021808
Receipt No. R000023736
Scientific Title The significance of oral L-carnitine administration in liver cirrhotic patients -a comparative study of treatment efficacy and safety between L-carnitine and lactulose in patients with minimal hepatic encephalopathy-
Date of disclosure of the study information 2016/05/01
Last modified on 2016/04/06

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Basic information
Public title The significance of oral L-carnitine administration in liver cirrhotic patients
-a comparative study of treatment efficacy and safety between L-carnitine and lactulose in patients with minimal hepatic encephalopathy-
Acronym The significance of oral L-carnitine administration in liver cirrhotic patients
Scientific Title The significance of oral L-carnitine administration in liver cirrhotic patients
-a comparative study of treatment efficacy and safety between L-carnitine and lactulose in patients with minimal hepatic encephalopathy-
Scientific Title:Acronym The significance of oral L-carnitine administration in liver cirrhotic patients
Region
Japan

Condition
Condition liver cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We perform the comparative study about the treatment efficacy and safety between each oral administration of L-carnitine and lactulose in patients with minimal hepatic encephalopathy(MHE).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A comparative study about the ameliorated rate of MHE
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
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 The oral L-carnitine administration is performed.
Interventions/Control_2 The oral lactulose administration is performed.
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 Those who are more than 20 years old, those who have performance status 0 or 1, those who have decompensated cirrhosis with minimal hepatic encephalopathy, or those who have consent about this study are included in this study.
Key exclusion criteria Those who have pregnancy, those who can not continue the treatment because of several diseases such as cancer therapy, or those who have difficulty for the enrollment of this study are excluded in this study.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihiko Yano
Organization Kobe University Graduate School of Medicine
Division name Center for Infectious Diseases
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL 078-382-6305
Email yanoyo@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Hayashi
Organization Kobe University Hospital
Division name Division of Gastroenterology
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL 078-382-6305
Homepage URL
Email hhayashi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University Hospital
Division of Gastroenterology
Institute
Department

Funding Source
Organization Kobe University Hospital
Division of Gastroenterology
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
Address
Tel
Email

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
2016 Year 05 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 Preinitiation
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 05 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

Management information
Registered date
2016 Year 04 Month 06 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023736

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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