UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025034 |
|---|---|
| Receipt number | 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 00:29:18 |
* 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 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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028798
