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

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ClinicalTrials.gov Identifier: NCT03222206
Recruitment Status : Completed
First Posted : July 19, 2017
Last Update Posted : August 22, 2019
Sponsor:
Collaborator:
Kuhnil Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Ji Hoon Kim, Korea University Guro Hospital

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
Non Alcoholic Fatty Liver Osteo Arthritis Drug: Salsalate Other: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Salsalate (2g/d), Place (2g/d)
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease: Investigator Initiated Randomized Placebo-controlled Double-blind, Pilot Study
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : February 22, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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


Outcome Measures
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Primary Outcome Measures :
  1. Change of controlled attenuation parameter [ Time Frame: baseline and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group

  2. Change of hepatokine as Fetuin-A [ Time Frame: baseline and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group

  3. Change of pulse wave velocity [ Time Frame: baseline and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group

  4. Change of adipokine as Adiponectin [ Time Frame: baseline and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group


Secondary Outcome Measures :
  1. Change of controlled attenuation parameter [ Time Frame: baseline and 4weeks ]
    Estimation of salsalate single injection group and placebo injection group

  2. Change of hepatokine as Fetuin-A [ Time Frame: baseline and 4weeks ]
    Estimation of salsalate single injection group and placebo injection group

  3. Change of pulse wave velocity [ Time Frame: baseline and 4weeks ]
    Estimation of salsalate single injection group and placebo injection group

  4. Change of adipokine as Adiponectin [ Time Frame: baseline and 4weeks ]
    Estimation of salsalate single injection group and placebo injection group

  5. Numerical value change of fatty liver index [ Time Frame: baseline, 4weeks and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group

  6. 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

  7. 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

  8. 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

  9. 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

  10. Change of liver fibrosis factors as hyaluronic acid [ Time Frame: baseline, 4weeks and 8weeks ]
    Estimation of salsalate single injection group and placebo injection group

  11. 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

  12. 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

  13. Stability comparison like side effect [ Time Frame: Up to 2month ]
    Estimation with treatment-related adverse events as assessed by CTCAE v4.0


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222206


Locations
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Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of, 08308
Sponsors and Collaborators
Korea University Guro Hospital
Kuhnil Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Ji Hoon Kim, MD Associate Professor
More Information
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Publications:

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Responsible Party: Ji Hoon Kim, Associate professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03222206    
Other Study ID Numbers: KUGH16353
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ji Hoon Kim, Korea University Guro Hospital:
Hepatokine
Adipokine
Saccharometabolism
Lipid metabolism
Additional relevant MeSH terms:
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Osteoarthritis
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Digestive System Diseases
 Salicylsalicylic acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents