UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008723 |
|---|---|
| Receipt number | R000009269 |
| Scientific Title | The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2012/08/20 10:02:09 |
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Basic information
Public title
The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study
Acronym
Carnitine supplementation for the liver cirrhosis
Scientific Title
The effect of carnitine supplementation for the liver cirrhosis patients with hyperammonemia -a preliminary randomized controlled study
Scientific Title:Acronym
Carnitine supplementation for the liver cirrhosis
Region
| Japan |
Condition
Condition
Cirrhosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate improvement of hyperammonemia by supplementation of carnitine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to evaluate the change of blood ammonia level.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Study drug was 600mg t.d.s. carnitine per day for 8weeks.
Interventions/Control_2
Study drug was 900mg t.d.s. carnitine per day for 8weeks.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Liver cirrhosis patients who complicated hyperammonemia, despite of taking dietary management more than 30 days.
Key exclusion criteria
1.Patients who are difficult to continue this study for treatment of hepatocarcinoma.
2.Patients complicated uncontrolled diabets.
3.Patients who diagnosed unfitness to attend the study by a physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Shiraishi |
Organization
Tokai University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
143 Shimokasuya, Isehara city, Kanagawa 259-1193
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokai University School of Medicine
Division name
Department of Internal Medicine
Zip code
Address
143 Shimokasuya, Isehara city, Kanagawa 259-1193
TEL
+81-463-93-1121
Homepage URL
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Tokai University School of Medicine
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
| 2012 | Year | 08 | Month | 20 | 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
| 2012 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2012 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009269
