A Phase 4 interventional study of Eupatilin and Rebamipide in Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis, sponsored by Seoul National University Boramae Hospital. Status unknown. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-13.
Sponsored by Seoul National University Boramae Hospital · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the efficacy of eupatilin on the prevention of gastroenteropathy in patients with NSAIDs and low dose steroid by comparing with rebamipide.
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At week 0, subjects who meet the eligibility criteria will be randomized in a open labeled manner in 1:1 ratio to eupatilin (90mg twice daily-test group, 25 patients) or rebamipide (100mg three times daily-control group paients) for 8 weeks. At week 8, subjects undergo fecal calprotectin test, upper endoscopy and submit symptom diary.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 50 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Seoul National University Boramae Hospital is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
take eupatilin to prevent NSAID induced gastroenteropathy
Drug: Eupatilin
take rebamipide to prevent NSAID induced gastroenteropathy
Drug: Rebamipide
take eupatilin to prevent NSAID induced gastroenteropathy
take rebamipide to prevent NSAID induced gastroenteropathy
Percentage of patients with gastric damage
Percentage of patients with endoscopic Modified Lanza Score \>3
Time frame: evaluated at day 56
Change of gastric erosion number
Change of gastric erosion number at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Change of Modified Lanza Score
Change of Modified Lanza Score at day 56 compared with that at day 0
Time frame: evaluated at 0 day and day 56
Change of duodenal erosion number
Change of duodenal erosion number at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Gastrointestinal symptom
Gastrointestinal symptom change using survey at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Fecal calprotectin
Fecal calprotectin level change at visit 3 compared with visit 0
Time frame: evaluated at day 0 and day 56
Antioxidant gene expression
Antioxidant gene expression change at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
No study locations are listed for this record.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Start is estimated for Jun 2021; primary completion for Dec 2021, 6 months later.
Of 79 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 92. This study's planned 6 months is below that.
Counting every sponsor, half of 104 studies reached it within 42 months; a quarter within 25 and three quarters within 74.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Seoul National University Boramae Hospital