The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease

• Status: Completed
• Trial end date: 2019-02-22
• Target enrollment: 0
• Participant gender: All

Summary

This Study purpose to verify change of variety factors that the cause of nonalcoholic fatty liver disease and its process through salsalate injection to osteoarthritis patient who has non alcoholic fatty liver

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Guro Hospital
• Collaborator: Kuhnil Pharmaceutical Co., Ltd.
• Treatments: Salicylsalicylic acid; Sodium Salicylate

Criteria

Inclusion Criteria:

• Osteoarthritis patient who has non alcoholic fatty liver

• Standard of non alcoholic fatty liver diagnosis

1. Fatty liver on abdominal ultrasonography

2. Patient who has no evidence as hepatitis B, hepatitis C, immune hepatitis, metabolic hepatitis and other chronic hepatitis

• Osteoarthritis patient who has never been treated

Exclusion Criteria:

• Unsuitable on inclusion criteria

• Thiazolidinedione injected patient for diabetes treatment or patient who has changed injected drug last 6 month

• Patient who is treating nonsteroidal antiinflammatory drugs for osteoarthritis

• Renal dysfunction : serum creatinine level 1.5mg/dl or creatinine clearance < 60ml/min

• Anamnesis of gastrointestinal tract bleeding

• Upper 5 times(200IU/l) the normality of Aspartate Transaminase(AST), Alanine Transaminase(ALT)

• Pregnant or Breastfeeding

• Patient who has untreated malignant tumor

• Liver transplantation patient

• Patient who has liver function Child-Pugh B over

• Patient who has serious disease that was estimated influence to study (e.g. Congestive heart failure, Kidney failure, Chronic pancreatitis, Malignant tumor)

• Patients who has been injected immunomodulatory and immunosuppressant(inclusive universal corticosteroids) before 6 month enrollment or at present

• Patient who was judged unsuitable for study by investigator