Ankylosing Spondylitis, Enteritis, Gastric Ulcer, NSAID-Associated Gastropathy, NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy, Osteoarthritis, Other Musculoskeletal Disorder, Rheumatoid Arthritis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGEupatilin
take eupatilin to prevent NSAID induced gastroenteropathy
DRUGRebamipide
take rebamipide to prevent NSAID induced gastroenteropathy
Sponsors
Dong-A ST Co., Ltd.
Seoul National University Boramae Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women who were adults at the time of receipt of written consent (age 19-70) 2. Those with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other musculoskeletal diseases that require continuous administration of nonsteroidal anti-inflammatory drugs (NSAIDs) and oral steroids for more than 8 weeks. 3. At screening (before baseline) endoscopy results Modified Lanza Score (MLS) 0\ 2 4. Those who have not had severe gastrointestinal symptoms in the previous 3 months\[Excluding mild abdominal distention, abdominal pain, diarrhea, dyspepsia, nausea, and vomiting\] 5. A person who agrees to participate in this clinical trial and voluntarily signs a written consent form
Exclusion criteria
1. Those with a history of gastrointestinal surgery (excluding appendectomy) 2. Those who have a history of esophageal cancer, liver cancer, pancreatic cancer, gastric cancer, colon cancer, small intestine tumor or other malignant disease within 5 years from the time of screening 3. Gastrointestinal diseases that are clinically significant by upper gastrointestinal endoscopy, namely active peptic ulcer, reflux esophagitis, gastroesophageal varices, Barrett's esophagus, Barrett's esophagitis, esophageal stenosis, inflammatory bowel disease (Those diagnosed with inflammatory bowel disease, IBD), gastrointestinal bleeding, etc. 4. Those with a history of recurrent gastrointestinal ulcer/perforation 5. Those with cerebrovascular bleeding or confirmed systemic bleeding disorder 6. Persons with severe uncontrolled heart failure (NYHA Class III-IV), high blood pressure (above 160/100 mmHg) 7. Those who have plans for surgical operation during the clinical trial period 8. Persons with a history of chronic pancreatitis, chronic renal diseases, chronic liver diseases, or other serious comorbid diseases 9. Those with clinically significant abnormal values (AST, ALT, BUN, Cr exceeding 2.5 times or Hb\<10g/dL) by laboratory examination 10. Those with a history of alcohol or drug abuse/dependence 11. Pregnant and lactating women 12. Those who participated in other clinical trials within 30 days prior to participation in this clinical trial and received investigational drugs or received procedures 13. Patients who are difficult to perform this clinical trial by other investigators or who are judged to have medical findings that are not suitable for the clinical trial 14. Those who received celecoxib and prednisolone (or methylprednisolone) within 30 days prior to participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with gastric damage | evaluated at day 56 | Percentage of patients with endoscopic Modified Lanza Score \>3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Modified Lanza Score | evaluated at 0 day and day 56 | Change of Modified Lanza Score at day 56 compared with that at day 0 |
| Change of duodenal erosion number | evaluated at day 0 and day 56 | Change of duodenal erosion number at day 56 compared with that at day 0 |
| Change of gastric erosion number | evaluated at day 0 and day 56 | Change of gastric erosion number at day 56 compared with that at day 0 |
| Fecal calprotectin | evaluated at day 0 and day 56 | Fecal calprotectin level change at visit 3 compared with visit 0 |
| Antioxidant gene expression | evaluated at day 0 and day 56 | Antioxidant gene expression change at day 56 compared with that at day 0 |
| Gastrointestinal symptom | evaluated at day 0 and day 56 | Gastrointestinal symptom change using survey at day 56 compared with that at day 0 |
Outcome results
None listed