UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040441 |
|---|---|
| Receipt number | R000046141 |
| Scientific Title | The investigation for the usefulness of carnitine medication in patients with decompensated liver cirrhosis |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/11/16 21:10:10 |
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Basic information
Public title
The investigation for the usefulness of carnitine medication in patients with decompensated liver cirrhosis
Acronym
The usefulness of carnitine medication in patients with decompensated liver cirrhosis
Scientific Title
The investigation for the usefulness of carnitine medication in patients with decompensated liver cirrhosis
Scientific Title:Acronym
The usefulness of carnitine medication in patients with decompensated liver cirrhosis
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the improvement rate of Child-Pugh score after 12weeks from medication start
Key secondary outcomes
the change of grasping power, muscle mass, serum ammonia, neuropsychological test
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 not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
L-carnitine 1500mg/day medication for 12 weeks
Interventions/Control_2
non administration group
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
The decompensated liver cirrhosis patients with Child-Pugh score over 7 points
Key exclusion criteria
1)The patient who has already taken carnitine
2)The pregnant woman
3)The breast-feeding women
4)The patient who received other study medicine or the clinical experimental medicine within three months before dosage start of the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akinobu |
| Middle name | |
| Last name | Takaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL
086-235-7219
akitaka@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Adachi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
7008558
Address
2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
TEL
086-235-7219
Homepage URL
adataku719@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
epartment of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address
2-5-1 Sikatacho, Kitaku, Okayama city, Okayama, japan
Tel
086-235-6610
chiken@okayama-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
0
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
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046141
