UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013787 |
|---|---|
| Receipt number | R000014428 |
| Scientific Title | Freqency of Carnitine Deficiency in Patients with Chronic Liver Disease, and Efficacy of Oral L-Carnitine Treatment for Patiens with Liver Cirrhosis |
| Date of disclosure of the study information | 2014/04/24 |
| Last modified on | 2023/10/31 13:28:28 |
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Basic information
Public title
Freqency of Carnitine Deficiency in Patients with Chronic Liver Disease, and Efficacy of Oral L-Carnitine Treatment for Patiens with Liver Cirrhosis
Acronym
Freqency of Carnitine Deficiency in Patients with Chronic Liver Disease, and Efficacy of Oral L-Carnitine Treatment for Patiens with Liver Cirrhosis
Scientific Title
Freqency of Carnitine Deficiency in Patients with Chronic Liver Disease, and Efficacy of Oral L-Carnitine Treatment for Patiens with Liver Cirrhosis
Scientific Title:Acronym
Freqency of Carnitine Deficiency in Patients with Chronic Liver Disease, and Efficacy of Oral L-Carnitine Treatment for Patiens with Liver Cirrhosis
Region
| Japan |
Condition
Condition
Simple fatty liver, non-alcohoic steatohepatitis, alcoholic liver disease, and liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1st step: To evaluate the serum levels of carnitin between healthy volunteer and non-viral chronic liver desease.
2nd step: To evaluate the efficacy and safety of L-carnitine for patients with non-viral liver cirrhosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1st step: To evaluate the serum levels of carnitin between healthy volunteer and non-viral chronic liver desease.
2nd step: To evaluate the improvement of liver function with non-viral liver cirrhosis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
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
L-carnitine 600mg P.O. three times per day, dietary counselling and exercise counselling for 12 weeks
Interventions/Control_2
dietary and exercise counselling for 12 weeks
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Histologically proven or clinically diagnosed liver cirrhosis,chronic liver disease (excluded viral hepatitis), and healthy volunteer
2) Written informed consent
3) Patient's age ranges from 20 to 85 years, and healthy volunteer.
Key exclusion criteria
1) Pregnant and lactating females
2) Hisotry of drug allergy
3) Inappropriate for entry onto this study in the judgment of the investigator
4) Administration of other test drugs within 1 month
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAMURA Takefumi |
Organization
Kansai Denryoku Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Fukushima2-1-7, Fukushima-ku, Osaka-ci, Osaka
TEL
06-6458-5821
nakamura.takefumi@a5.kepco.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SANDO Takehiro |
Organization
Hoshigaoka Medical Center
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Hoshigaoka 4-8-1. Hirakata-ci, Osaka
TEL
072-640-2641
Homepage URL
sando@takepapi.com
Sponsor or person
Institute
Kansai Study Group of Liver Steatosis(KASALS)
Institute
Department
Personal name
Funding Source
Organization
Kansai Study Group of Liver Steatosis(KASALS)
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
| 2014 | Year | 04 | Month | 24 | 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 | 05 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014428
| 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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