NCT03222206

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

The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease: Investigator Initiated Randomized Placebo-controlled Double-blind, Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Non Alcoholic Fatty Liver
• Osteo Arthritis

Interventions

Type	Name	Description
DRUG	Salsalate	1. Medicate salsalate 2g/day after run-in period 2. Check side effect after 1 month and Control dosage (2g/day or 3g/day) 3. Check side effect after 2 month
OTHER	Placebo	1. Medicate placebo 2g/day after run-in period 2. Check side effect after 1 month and Control dosage (2g/day or 3g/day) 3. Check side effect after 2 month

Timeline

• Start date: 2017-11-08
• Primary completion: 2019-02-22
• Completion: 2019-02-22
• First posted: 2017-07-19
• Last updated: 2019-08-22

Locations

1 site across 1 country: South Korea