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

August 21, 2019 updated by: Ji Hoon Kim, Korea University Guro Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salsalate
17 patients received continuous medication with salsalate 2g/day after run-in period
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 Names:
  • A03850041
Placebo Comparator: Placebo
17 patients received continuous medication with Placebo 2g/day after run-in period
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of controlled attenuation parameter
Time Frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 8weeks
Change of hepatokine as Fetuin-A
Time Frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 8weeks
Change of pulse wave velocity
Time Frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 8weeks
Change of adipokine as Adiponectin
Time Frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 8weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of controlled attenuation parameter
Time Frame: baseline and 4weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 4weeks
Change of hepatokine as Fetuin-A
Time Frame: baseline and 4weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 4weeks
Change of pulse wave velocity
Time Frame: baseline and 4weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 4weeks
Change of adipokine as Adiponectin
Time Frame: baseline and 4weeks
Estimation of salsalate single injection group and placebo injection group
baseline and 4weeks
Numerical value change of fatty liver index
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Numerical value change of hepatic fibrosis as Nonalcoholic Fatty Liver Disease(NAFLD) fibrosis score
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of saccharometabolic factors as Homeostasis Model Assessment(HOMA)-Insulin Resistance(IR), Homeostasis Model Assessment(HOMA)-B, Fasting glucose, Insulin, C-peptide, HbA1c, Glycated albumin
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of lipid metabolic factors as Cholesterol, Triglyceride, LDL-cholesterol HDL-cholesterol and liver function test as Aspartate Transaminase(AST) and Alanine Transaminase(ALT)
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of inflammatory factors as C Reactive Protein(CRP), Tumor Necrosis Factor(TNF)-a
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of liver fibrosis factors as hyaluronic acid
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of symptom of osteoarthritis as visual analog score for pain
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Change of function of osteoarthritis as WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
Time Frame: baseline, 4weeks and 8weeks
Estimation of salsalate single injection group and placebo injection group
baseline, 4weeks and 8weeks
Stability comparison like side effect
Time Frame: Up to 2month
Estimation with treatment-related adverse events as assessed by CTCAE v4.0
Up to 2month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University Guro Hospital

Collaborators

Kuhnil Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2017

Primary Completion (Actual)

February 22, 2019

Study Completion (Actual)

February 22, 2019

Study Registration Dates

First Submitted

July 8, 2017

First Submitted That Met QC Criteria

July 16, 2017

First Posted (Actual)

July 19, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 21, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUGH16353

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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