Non Alcoholic Fatty LiverPhase 4NCT03222206
The Comparison of Effect Between Salsalate and Placebo in Osteoarthritis With Nonalcoholic Fatty Liver Disease
A Phase 4 study testing Salsalate in people with Non Alcoholic Fatty Liver and Osteo Arthritis, run by Korea University Guro Hospital at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non Alcoholic Fatty Liver, Osteo Arthritis
- What is being tested?
- Salsalate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2017to 22 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Being tested
- Salsalate, Placebo
- Keywords
- Hepatokine, Adipokine, Saccharometabolism, Lipid metabolism
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalsalateDrug
Also called A03850041
- Medicate salsalate 2g/day after run-in period
- Check side effect after 1 month and Control dosage (2g/day or 3g/day)
- Check side effect after 2 month
PlaceboOther
- Medicate placebo 2g/day after run-in period
- Check side effect after 1 month and Control dosage (2g/day or 3g/day)
- Check side effect after 2 month
| Study group | Role | What they receive |
|---|---|---|
| Salsalate | Experimental | 17 patients received continuous medication with salsalate 2g/day after run-in period Receives: Drug: Salsalate |
| Placebo | Placebo comparator | 17 patients received continuous medication with Placebo 2g/day after run-in period Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of controlled attenuation parameter
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 8weeks
Change of hepatokine as Fetuin-A
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 8weeks
Change of pulse wave velocity
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 8weeks
Change of adipokine as Adiponectin
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 8weeks
Secondary outcomes (13)
Change of controlled attenuation parameter
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 4weeks
Change of hepatokine as Fetuin-A
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 4weeks
Change of pulse wave velocity
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 4weeks
Change of adipokine as Adiponectin
Estimation of salsalate single injection group and placebo injection group
Measured: baseline and 4weeks
Numerical value change of fatty liver index
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Numerical value change of hepatic fibrosis as Nonalcoholic Fatty Liver Disease(NAFLD) fibrosis score
Estimation of salsalate single injection group and placebo injection group
Measured: 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
Estimation of salsalate single injection group and placebo injection group
Measured: 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)
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Change of inflammatory factors as C Reactive Protein(CRP), Tumor Necrosis Factor(TNF)-a
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Change of liver fibrosis factors as hyaluronic acid
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Change of symptom of osteoarthritis as visual analog score for pain
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Change of function of osteoarthritis as WOMAC (The Western Ontario and McMaster Universities Osteoarthritis Index)
Estimation of salsalate single injection group and placebo injection group
Measured: baseline, 4weeks and 8weeks
Stability comparison like side effect
Estimation with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Up to 2month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start8 Nov 2017
- Primary completion22 Feb 2019
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Non Alcoholic Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Salsalate (2g/d), Place (2g/d)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kuhnil Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ji Hoon Kim, Korea University Guro Hospital
- Investigators
- Ji Hoon Kim, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222206
- Sponsor's protocol ID
- KUGH16353
- Status last verified
- Aug 2019
- First submitted
- 8 Jul 2017
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bae JC, Cho YK, Lee WY, Seo HI, Rhee EJ, Park SE, Park CY, Oh KW, Sung KC, Kim BI. Impact of nonalcoholic fatty liver disease on insulin resistance in relation to HbA1c levels in nondiabetic subjects. Am J Gastroenterol. 2010 Nov;105(11):2389-95. doi: 10.1038/ajg.2010.275. Epub 2010 Jul 13.
PubMed 20628364Choi SY, Kim D, Kim HJ, Kang JH, Chung SJ, Park MJ, Kim YS, Kim CH, Choi SH, Kim W, Kim YJ, Yoon JH, Lee HS, Cho SH, Sung MW, Oh BH. The relation between non-alcoholic fatty liver disease and the risk of coronary heart disease in Koreans. Am J Gastroenterol. 2009 Aug;104(8):1953-60. doi: 10.1038/ajg.2009.238. Epub 2009 Jun 2.
PubMed 19491838Clark 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.
PubMed 16540768Musso G, Cassader M, Gambino R. Diagnostic accuracy of adipose insulin resistance index and visceral adiposity index for progressive liver histology and cardiovascular risk in nonalcoholic fatty liver disease. Hepatology. 2012 Aug;56(2):788-9. doi: 10.1002/hep.25677. No abstract available.
PubMed 22371327Kim D, Choi SY, Park EH, Lee W, Kang JH, Kim W, Kim YJ, Yoon JH, Jeong SH, Lee DH, Lee HS, Larson J, Therneau TM, Kim WR. Nonalcoholic fatty liver disease is associated with coronary artery calcification. Hepatology. 2012 Aug;56(2):605-13. doi: 10.1002/hep.25593. Epub 2012 Jul 2.
PubMed 22271511Mahady SE, Webster AC, Walker S, Sanyal A, George J. The role of thiazolidinediones in non-alcoholic steatohepatitis - a systematic review and meta analysis. J Hepatol. 2011 Dec;55(6):1383-90. doi: 10.1016/j.jhep.2011.03.016. Epub 2011 Apr 14.
PubMed 21703200Aithal GP, Thomas JA, Kaye PV, Lawson A, Ryder SD, Spendlove I, Austin AS, Freeman JG, Morgan L, Webber J. Randomized, placebo-controlled trial of pioglitazone in nondiabetic subjects with nonalcoholic steatohepatitis. Gastroenterology. 2008 Oct;135(4):1176-84. doi: 10.1053/j.gastro.2008.06.047. Epub 2008 Jun 25.
PubMed 18718471Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307. doi: 10.1056/NEJMoa060326.
PubMed 17135584Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437.
PubMed 21990298Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.
PubMed 18223031Cohen A. Fecal blood loss and plasma salicylate study of salicylsalicylic acid and aspirin. J Clin Pharmacol. 1979 Apr;19(4):242-7. doi: 10.1002/j.1552-4604.1979.tb01658.x.
PubMed 312297Esser N, Paquot N, Scheen AJ. Anti-inflammatory agents to treat or prevent type 2 diabetes, metabolic syndrome and cardiovascular disease. Expert Opin Investig Drugs. 2015 Mar;24(3):283-307. doi: 10.1517/13543784.2015.974804. Epub 2014 Oct 25.
PubMed 25345753Ridker PM, Luscher TF. Anti-inflammatory therapies for cardiovascular disease. Eur Heart J. 2014 Jul 14;35(27):1782-91. doi: 10.1093/eurheartj/ehu203. Epub 2014 May 26.
PubMed 24864079Alderete 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.
PubMed 25644856Pierce GL, Lesniewski LA, Lawson BR, Beske SD, Seals DR. Nuclear factor-kappaB activation contributes to vascular endothelial dysfunction via oxidative stress in overweight/obese middle-aged and older humans. Circulation. 2009 Mar 10;119(9):1284-92. doi: 10.1161/CIRCULATIONAHA.108.804294. Epub 2009 Feb 23.
PubMed 19237660
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03222206
- Acronym / sponsor ID
- KUGH16353
- Conditions
- Non Alcoholic Fatty Liver, Osteo Arthritis
- Keywords
- Hepatokine, Adipokine, Saccharometabolism, Lipid metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Kuhnil Pharmaceutical Co., Ltd.
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 22 Feb 2019 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Salsalate (2g/d), Place (2g/d)
| Arm | Type | Receives |
|---|---|---|
| Salsalate | Experimental | Drug: Salsalate17 patients received continuous medication with salsalate 2g/day after run-in period |
| Placebo | Placebo comparator | Other: Placebo17 patients received continuous medication with Placebo 2g/day after run-in period |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Osteoarthritis patient who has non alcoholic fatty liver
- Standard of non alcoholic fatty liver diagnosis
- Osteoarthritis patient who has never been treated
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalsalateAlso: A038500411. 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 | Drug | Salsalate |
| Placebo1. 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 | Other | Placebo |
Primary outcome
Change of controlled attenuation parameter
Time frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of hepatokine as Fetuin-A
Time frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of pulse wave velocity
Time frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
Change of adipokine as Adiponectin
Time frame: baseline and 8weeks
Estimation of salsalate single injection group and placebo injection group
13 secondary outcomes
Change of controlled attenuation parameter
Time frame: baseline and 4weeks
Change of hepatokine as Fetuin-A
Time frame: baseline and 4weeks
Change of pulse wave velocity
Time frame: baseline and 4weeks
Change of adipokine as Adiponectin
Time frame: baseline and 4weeks
Numerical value change of fatty liver index
Time frame: baseline, 4weeks and 8weeks
Numerical value change of hepatic fibrosis as Nonalcoholic Fatty Liver Disease(NAFLD) fibrosis score
Time frame: 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
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
Change of inflammatory factors as C Reactive Protein(CRP), Tumor Necrosis Factor(TNF)-a
Time frame: baseline, 4weeks and 8weeks
Change of liver fibrosis factors as hyaluronic acid
Time frame: baseline, 4weeks and 8weeks
Change of symptom of osteoarthritis as visual analog score for pain
Time frame: 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
Stability comparison like side effect
Time frame: Up to 2month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Background: PubMed 20628364Bae JC, Cho YK, Lee WY, Seo HI, Rhee EJ, Park SE, Park CY, Oh KW, Sung KC, Kim BI. Impact of nonalcoholic fatty liver disease on insulin resistance in relation to HbA1c levels in nondiabetic subjects. Am J Gastroenterol. 2010 Nov;105(11):2389-95. doi: 10.1038/ajg.2010.275. Epub 2010 Jul 13.
- Background: PubMed 19491838Choi SY, Kim D, Kim HJ, Kang JH, Chung SJ, Park MJ, Kim YS, Kim CH, Choi SH, Kim W, Kim YJ, Yoon JH, Lee HS, Cho SH, Sung MW, Oh BH. The relation between non-alcoholic fatty liver disease and the risk of coronary heart disease in Koreans. Am J Gastroenterol. 2009 Aug;104(8):1953-60. doi: 10.1038/ajg.2009.238. Epub 2009 Jun 2.
- Background: PubMed 16540768Clark 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.
- Background: PubMed 22371327Musso G, Cassader M, Gambino R. Diagnostic accuracy of adipose insulin resistance index and visceral adiposity index for progressive liver histology and cardiovascular risk in nonalcoholic fatty liver disease. Hepatology. 2012 Aug;56(2):788-9. doi: 10.1002/hep.25677. No abstract available.
- Background: PubMed 22271511Kim D, Choi SY, Park EH, Lee W, Kang JH, Kim W, Kim YJ, Yoon JH, Jeong SH, Lee DH, Lee HS, Larson J, Therneau TM, Kim WR. Nonalcoholic fatty liver disease is associated with coronary artery calcification. Hepatology. 2012 Aug;56(2):605-13. doi: 10.1002/hep.25593. Epub 2012 Jul 2.
- Background: PubMed 21703200Mahady SE, Webster AC, Walker S, Sanyal A, George J. The role of thiazolidinediones in non-alcoholic steatohepatitis - a systematic review and meta analysis. J Hepatol. 2011 Dec;55(6):1383-90. doi: 10.1016/j.jhep.2011.03.016. Epub 2011 Apr 14.
- Background: PubMed 18718471Aithal GP, Thomas JA, Kaye PV, Lawson A, Ryder SD, Spendlove I, Austin AS, Freeman JG, Morgan L, Webber J. Randomized, placebo-controlled trial of pioglitazone in nondiabetic subjects with nonalcoholic steatohepatitis. Gastroenterology. 2008 Oct;135(4):1176-84. doi: 10.1053/j.gastro.2008.06.047. Epub 2008 Jun 25.
- Background: PubMed 17135584Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307. doi: 10.1056/NEJMoa060326.
- Background: PubMed 21990298Klein EA, Thompson IM Jr, Tangen CM, Crowley JJ, Lucia MS, Goodman PJ, Minasian LM, Ford LG, Parnes HL, Gaziano JM, Karp DD, Lieber MM, Walther PJ, Klotz L, Parsons JK, Chin JL, Darke AK, Lippman SM, Goodman GE, Meyskens FL Jr, Baker LH. Vitamin E and the risk of prostate cancer: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA. 2011 Oct 12;306(14):1549-56. doi: 10.1001/jama.2011.1437.
- Background: PubMed 18223031Kahn SE, Zinman B, Lachin JM, Haffner SM, Herman WH, Holman RR, Kravitz BG, Yu D, Heise MA, Aftring RP, Viberti G; Diabetes Outcome Progression Trial (ADOPT) Study Group. Rosiglitazone-associated fractures in type 2 diabetes: an Analysis from A Diabetes Outcome Progression Trial (ADOPT). Diabetes Care. 2008 May;31(5):845-51. doi: 10.2337/dc07-2270. Epub 2008 Jan 25.
- Background: PubMed 312297Cohen A. Fecal blood loss and plasma salicylate study of salicylsalicylic acid and aspirin. J Clin Pharmacol. 1979 Apr;19(4):242-7. doi: 10.1002/j.1552-4604.1979.tb01658.x.
- Background: PubMed 25345753Esser N, Paquot N, Scheen AJ. Anti-inflammatory agents to treat or prevent type 2 diabetes, metabolic syndrome and cardiovascular disease. Expert Opin Investig Drugs. 2015 Mar;24(3):283-307. doi: 10.1517/13543784.2015.974804. Epub 2014 Oct 25.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hoon Kim, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salsalate in people with Non Alcoholic Fatty Liver and Osteo Arthritis, run by Korea University Guro Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of controlled attenuation parameter (time frame: baseline and 8weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03222206, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.