Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy

Phase 4

• Conditions: Enteritis; Rheumatoid Arthritis; NSAID-Associated Gastropathy; Ankylosing Spondylitis; Other Musculoskeletal Disorder; Gastric Ulcer; Osteoarthritis; NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy
• Interventions: Drug: Eupatilin; Drug: Rebamipide

• Registration Number: NCT04885751
• Lead Sponsor: Seoul National University Boramae Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-26
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13
• Study Start: 2021-06-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eupatilin	Eupatilin	take eupatilin to prevent NSAID induced gastroenteropathy
rebamipide	Rebamipide	take rebamipide to prevent NSAID induced gastroenteropathy

Primary Outcome Measures

Name	Time	Method
Percentage of patients with gastric damage	evaluated at day 56	Percentage of patients with endoscopic Modified Lanza Score \>3

Secondary Outcome Measures

Name	Time	Method
Gastrointestinal symptom	evaluated at day 0 and day 56	Gastrointestinal symptom change using survey 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
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
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 Modified Lanza Score	evaluated at 0 day and day 56	Change of Modified Lanza Score at day 56 compared with that at day 0
Antioxidant gene expression	evaluated at day 0 and day 56	Antioxidant gene expression change at day 56 compared with that at day 0