UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022552
Receipt number R000025857
Scientific Title Effect of carnitine to hyperammonemia of liver cirrhosis.
Date of disclosure of the study information 2016/05/31
Last modified on 2022/06/06 16:45:33

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Basic information

Public title

Effect of carnitine to hyperammonemia of liver cirrhosis.

Acronym

carnitine test

Scientific Title

Effect of carnitine to hyperammonemia of liver cirrhosis.

Scientific Title:Acronym

carnitine test

Region

Japan


Condition

Condition

Liver cirrhosis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Efficacy to improvement of hyperammonemia and hepatic encehploapty

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Depresion of serum ammonia after administraiton of carnitine (12W after)

Key secondary outcomes

Decrease evidence of hepatic encephaloapty
improvement of nuber conection test B


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 considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

carnitine1000mg/day 12weeks administration and compare between two groups

Interventions/Control_2

not treatment

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

1.not administration of carnitine within 2weeks before entry
2.more than 60ug/dL of serum ammonia

Key exclusion criteria

1.GI tract bleeding
2.giant shant vessels
3.malignat tumors which are out of control
4.patients who needs HD
5.pregnancy
6.patients who are considered as not suitable to this study

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Shunsuke
Middle name
Last name Nojiri

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code

4678601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan

TEL

052-853-8211

Email

snojiri@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Shunsuke
Middle name
Last name Nojiri

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Gastroenterology and Metabolism

Zip code

4678601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan

TEL

052-853-8211

Homepage URL


Email

snojiri@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

Nagoya City University Graduate School of Medical Sciences

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor

Nagoya daini red cross hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Nagoya City University Graduate School of Medical Sciences

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, 467-8601, Japan

Tel

528374859

Email

snojiri@med.nagoya-cu.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

名古屋市立大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 31 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

2016 Year 04 Month 08 Day

Date of IRB


Anticipated trial start date

2016 Year 05 Month 24 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

2016 Year 05 Month 31 Day

Last modified on

2022 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025857


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name