UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009761 |
|---|---|
| Receipt number | R000011437 |
| Scientific Title | Oral L-Carnitine Treatment in Hepatic Encephalopathy |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2018/09/07 13:37:55 |
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Basic information
Public title
Oral L-Carnitine Treatment in Hepatic Encephalopathy
Acronym
Oral L-Carnitine Stydy
Scientific Title
Oral L-Carnitine Treatment in Hepatic Encephalopathy
Scientific Title:Acronym
Oral L-Carnitine Stydy
Region
| Japan |
Condition
Condition
hepatic encephalopathy
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
L-carnitine treatment is associated with a significant reduction of blood and brain ammonia concentration. To evaluate the influence of L-carnitine on the patients with recurrent hepatic
encephalopathy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time to the first breakthrough episode of overt hepatic encephalopathy (>=grade 2).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral L-cartine treatment
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patient's age ranges from 20 to 80 years.
2. At least two episodes of overt hepatic encephalopathy (>=Grade 2) associated with hepatic cirrhosis during the previous 6 months, and remission (Grade 0 or 1) at enrollment.
3. Patient's prognosis should be longer than 6 months.
4. In-and Outpatients
5. Patients received document agreement with participation in this study.
Key exclusion criteria
1. Patient's prognosis is shorter than 6 months.
2. Child Pugh grade C
3. Spontaneous bacterial peritonitis
4. Alcoholism or antipsychotic drug user
5. Gastrointestinal hemorrhage
6. The placement of TIPS, B-RTO, or PSE.
7. Patients who judged inappropriate by researcher.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Takuma |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology
Zip code
Address
1-1-1 Miwa, Kurashiki, Okayama 710-8602 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukari Matsumoto |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Central Hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2013 | Year | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | 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
| 2013 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011437
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
