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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025034
Receipt No. R000028798
Scientific Title The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia
Date of disclosure of the study information 2016/11/29
Last modified on 2016/11/29

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Basic information
Public title The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia
Acronym The effect of carnitine for hyperammonemia
Scientific Title The effect of carnitine for chronic liver disease or liver cirrhosis with hyperammonemia
Scientific Title:Acronym The effect of carnitine for hyperammonemia
Region
Japan

Condition
Condition Chronic liver disease with hyperammonemia
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To make clear the dfffect of carnitine for hypaerammonemia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decrease of ammonia after carnitine administration
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 standard therapy treated generaly
Interventions/Control_2 carnitine administration (1000mg/day, 3 months)
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.Informed consent was obtained
2.Patients has not receive carnitine before 2 weeks
3.chronic liver damage and liver cirrhosis who has serum ammonia more than 60ug/dL
4.hepatic encephalopathy or positive of number conection test B
Key exclusion criteria 1.GI tract bleeding
2.Patients experienced adverse events
3.Giant shunt of vessels
4.dementia
5.malignat tumor which is uncontroled
6.Allergic reaction for carnitine
7.Patients who administrate drugs that introduce hyperammonemia
8.Patients receive dialysis
9.Patients who is pregnant
Target sample size 140

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunsuke Nojiri
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL +81-52-853-8211
Email snojiri@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Nojiri
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Gastroenterology and Metabolism
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya
TEL +81-52-853-8211
Homepage URL
Email snojiri@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization none
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 11 Month 29 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 Open public recruiting
Date of protocol fixation
2016 Year 04 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 26 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 11 Month 29 Day
Last modified on
2016 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028798

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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