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

NCT03222206 | Completed Phase 4 DMC

• 1 other identifier: KUGH16353
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Non Alcoholic Fatty Liver; Osteo Arthritis

Keywords

Hepatokine; Adipokine; Saccharometabolism; Lipid metabolism

Outcome Measures

Primary Outcomes (4)

• Change of controlled attenuation parameter

  Estimation of salsalate single injection group and placebo injection group

  baseline and 8weeks

• Change of hepatokine as Fetuin-A

  Estimation of salsalate single injection group and placebo injection group

  baseline and 8weeks

• Change of pulse wave velocity

  Estimation of salsalate single injection group and placebo injection group

  baseline and 8weeks

• Change of adipokine as Adiponectin

  Estimation of salsalate single injection group and placebo injection group

  baseline and 8weeks

Secondary Outcomes (13)

• Change of controlled attenuation parameter

  baseline and 4weeks

• Change of hepatokine as Fetuin-A

  baseline and 4weeks

• Change of pulse wave velocity

  baseline and 4weeks

• Change of adipokine as Adiponectin

  baseline and 4weeks

• Numerical value change of fatty liver index

  baseline, 4weeks and 8weeks

Study Arms (2)

Salsalate

EXPERIMENTAL

17 patients received continuous medication with salsalate 2g/day after run-in period

Drug: Salsalate

Placebo

PLACEBO COMPARATOR

17 patients received continuous medication with Placebo 2g/day after run-in period

Other: Placebo

Interventions

Salsalate DRUG

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

Also known as: A03850041

Salsalate

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Osteoarthritis patient who has non alcoholic fatty liver
• Standard of non alcoholic fatty liver diagnosis
• Fatty liver on abdominal ultrasonography
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Guro Hospital: lead
• Kuhnil Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Related Publications (21)

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  PMID: 19491838 BACKGROUND

• Clark JM. The epidemiology of nonalcoholic fatty liver disease in adults. J Clin Gastroenterol. 2006 Mar;40 Suppl 1:S5-10. doi: 10.1097/01.mcg.0000168638.84840.ff.

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• Alderete TL, Sattler FR, Richey JM, Allayee H, Mittelman SD, Sheng X, Tucci J, Gyllenhammer LE, Grant EG, Goran MI. Salsalate treatment improves glycemia without altering adipose tissue in nondiabetic obese hispanics. Obesity (Silver Spring). 2015 Mar;23(3):543-51. doi: 10.1002/oby.20991. Epub 2015 Feb 3.

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• Fleischman A, Shoelson SE, Bernier R, Goldfine AB. Salsalate improves glycemia and inflammatory parameters in obese young adults. Diabetes Care. 2008 Feb;31(2):289-94. doi: 10.2337/dc07-1338. Epub 2007 Oct 24.

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MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Ji Hoon Kim, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Salsalate (2g/d), Place (2g/d)

Study Record Dates

• First Submitted: July 8, 2017
• First Posted: July 19, 2017
• Study Start: November 8, 2017
• Primary Completion: February 22, 2019
• Study Completion: February 22, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Locations

KR (1)