UnknownPhase 4

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

50 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range19 Years – 70 Years

SexALL

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Inclusion criteria

✓. Men and women who were adults at the time of receipt of written consent (age 19-70)
✓. 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.
✓. At screening (before baseline) endoscopy results Modified Lanza Score (MLS) 0\~2
✓. Those who have not had severe gastrointestinal symptoms in the previous 3 months\[Excluding mild abdominal distention, abdominal pain, diarrhea, dyspepsia, nausea, and vomiting\]
✓. A person who agrees to participate in this clinical trial and voluntarily signs a written consent form

Exclusion criteria

✕. Those with a history of gastrointestinal surgery (excluding appendectomy)
✕. 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
✕. 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.
✕. Those with a history of recurrent gastrointestinal ulcer/perforation
✕. Those with cerebrovascular bleeding or confirmed systemic bleeding disorder
✕. Persons with severe uncontrolled heart failure (NYHA Class III-IV), high blood pressure (above 160/100 mmHg)
✕. Those who have plans for surgical operation during the clinical trial period
✕. Persons with a history of chronic pancreatitis, chronic renal diseases, chronic liver diseases, or other serious comorbid diseases

What they're measuring

Percentage of patients with gastric damage

Timeframe: evaluated at day 56

Trial details

NCT IDNCT04885751

SponsorSeoul National University Boramae Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

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