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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013787
Receipt No. 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 2014/06/06

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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
Email 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
Email sando@takepapi.com

Sponsor
Institute Kansai Study Group of Liver Steatosis(KASALS)
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2012 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 06 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
2014 Year 04 Month 22 Day
Last modified on
2014 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014428

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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