JPRN-UMIN000004034Completed未知
A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia - A dose-comparative study of ursodeoxycholic acid in nonalcoholic steatohepatitis (NASH) with glucose metabolism disorder and dyslipidemia
Division of Gastroenterology, Saiseikai Suita Hospital0 sites60 target enrollmentStarted: August 13, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
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