UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022552 |
|---|---|
| Receipt number | R000025857 |
| Scientific Title | Effect of carnitine to hyperammonemia of liver cirrhosis. |
| Date of disclosure of the study information | 2016/05/31 |
| Last modified on | 2022/06/06 16:45:33 |
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Basic information
Public title
Effect of carnitine to hyperammonemia of liver cirrhosis.
Acronym
carnitine test
Scientific Title
Effect of carnitine to hyperammonemia of liver cirrhosis.
Scientific Title:Acronym
carnitine test
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy to improvement of hyperammonemia and hepatic encehploapty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Depresion of serum ammonia after administraiton of carnitine (12W after)
Key secondary outcomes
Decrease evidence of hepatic encephaloapty
improvement of nuber conection test B
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
carnitine1000mg/day 12weeks administration and compare between two groups
Interventions/Control_2
not treatment
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.not administration of carnitine within 2weeks before entry
2.more than 60ug/dL of serum ammonia
Key exclusion criteria
1.GI tract bleeding
2.giant shant vessels
3.malignat tumors which are out of control
4.patients who needs HD
5.pregnancy
6.patients who are considered as not suitable to this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nojiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan
TEL
052-853-8211
snojiri@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nojiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan
TEL
052-853-8211
Homepage URL
snojiri@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nagoya daini red cross hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan
Tel
528374859
snojiri@med.nagoya-cu.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
名古屋市立大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 31 | 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 | 05 | Month | 24 | 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 | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025857
