UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004034 |
|---|---|
| Receipt number | 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 17:28:25 |
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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
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
Sponsor or person
Institute
Division of Gastroenterology, Saiseikai Suita Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004852
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