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

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Boramae Hospital
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Rebamipide

Criteria

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