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

Korea University

Status and phase

Completed

Phase 4

Conditions

Non Alcoholic Fatty Liver

Osteo Arthritis

Treatments

Other: Placebo

Drug: Salsalate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03222206

KUGH16353

Details and patient eligibility

About

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

Full description

Salsalate, the salicylic acid dimer that is one of anti-inflammatory and kind of salicylate. Aspirin(Acetylated salicylic) is known as nonsteroidal anti-inflammatory, also salsalate is widely used painkiller and anti-inflammatory without prescription in Europe and America through the long time and it was approved as osteoarthritis and rheumarthritis treatment in Korea. Especially salsalate is switched to salicylic acid(active metabolite) 15% rate lower than the same dose of aspirin (3.5g vs. 5g).

Salsalate is cyclooxygenase antagonist, it make anti-inflammatory effect by hinder creation of variety inflammatory induction factors like interleukin-6, Tumor Necrosis Factor (TNF)-alpha, C-reactive protein. This anti-inflammatory reaction is known to block Nuclear Factor(NF)-kappaB gene action by hinder action of IkappaB kinase. Also salsalate was reported it has positive effect to gluco metabolism as performed role of insulin-sensitizing. Therefore, the above mechanism of salsalate was expected that it can be had positive effect to metabolic disease like diabetes and obesity, and related studies are performed considerably at present.

There is no clinical trial for non alcoholic fatty acid related salsalate, and there was the animal study result that salsalate may reduce occurence of non alcoholic fatty acid and fibrosis by hinder non alcoholic fatty acid creation and inflammation mediation path.

Therefore, 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

Enrollment

34 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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