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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004034
Receipt No. R000004852
Scientific Title A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Date of disclosure of the study information 2010/08/13
Last modified on 2014/02/12

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Basic information
Public title A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Acronym A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Scientific Title A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Scientific Title:Acronym A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Region
Japan

Condition
Condition Nonalcoholic steatohepatitis (NASH)
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of ursodeoxycholic acid in NASH with glucose metabolism disorder and dyslipidemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) Histological change in liver biopsies
2) Functional change in liver enzymes
3) Safety
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Administration of ursodeoxycholic acid (600mg/day)for 52 weeks
Interventions/Control_2 Administration of ursodeoxycholic acid (1200mg/day)for 52 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

Not applicable
Gender Male and Female
Key inclusion criteria The patient of NASH with the following complications:

1)The fatty liver by diagnostic imaging
2)The glucose metabolism disorder (type 2 diabetic or IGT)
3)dyslipidemia
Key exclusion criteria 1)During the pretreatment period, the patient treated with a choleretic drug, a glycyrrhizin-combination drug, an immunotherapeutic drug, an adrenal corticoid, a liver hydrolysate, an enhancement drug of liver function, a Saiko-prescription, a bile-acid sequestrant, a phlebotomy or a folk medicine which may affect the target disorder.

2)During the pretreatment period, the patient with a discontinuation, an alternation of dose or dosage regimen, or a new additional dosage of the following drug:
a) Antidiabetic drugs: an insulin preparation, a SU drug, a biguanide, an alpha-gluosidase inhibitor, a drug for postprandial hyperglycemia of the early phase, a DPP4 inhibitor, b) Anti-oxidants: a vitamin E preparation, a N-Accetyl-Cysteine preparation, c) Hypolipidemic drugs: a fibrate, a HMG-CoA reductase inhibitor, a probucol, an EPA capsule, an intestinal cholesterol-transporter inhibitor, d) Anti-hypertensive drugs: an angiotensin II receptor type-1 antagonist (ARB).

3)The patient with type1 or 2 of the Matteoni classification from biopsy examination.

4)The patient with cirrhosis diagnosed from biopsy examination (diagnosis as F4 from liver biopsy).

5)The patient in cancer therapy.

6)The patient with complete biliary atresia.

7)The patient in therapy of fulminant hepatitis.

8)The patient during pregnancy, feeding, intimation of pregnancy or intended pregnancy.

9)The patient with history of hypersensitivity to test drug

10)The patient who was diagnosed as an inappropriate one by the researcher.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Okanoue
Organization Saiseikai Suita Hospital
Division name Division of Gastroenterology
Zip code
Address 1-2 Kawazonocho, Suita, 564-0013, Japan
TEL 06-6382-1521
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Saiseikai Suita Hospital
Division name Division of Gastroenterology
Zip code
Address 1-2 Kawazonocho, Suita, 564-0013, Japan
TEL 06-6382-1521
Homepage URL
Email

Sponsor
Institute Division of Gastroenterology, Saiseikai Suita Hospital
Institute
Department

Funding Source
Organization non
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
2010 Year 08 Month 13 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 Completed
Date of protocol fixation
2010 Year 03 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 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
2010 Year 08 Month 12 Day
Last modified on
2014 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004852

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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