Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy (CEERS)

Seoul National University Boramae Hospital

Status and phase

Unknown

Phase 4

Conditions

Enteritis

Osteoarthritis

Gastric Ulcer

Ankylosing Spondylitis

NSAID-Associated Gastropathy

Other Musculoskeletal Disorder

Rheumatoid Arthritis

NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy

Treatments

Drug: Rebamipide

Drug: Eupatilin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04885751

Eupatilin_GEP_01

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

19 to 70 years old

Volunteers

Accepts Healthy Volunteers

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
Those with clinically significant abnormal values (AST, ALT, BUN, Cr exceeding 2.5 times or Hb<10g/dL) by laboratory examination
Those with a history of alcohol or drug abuse/dependence
Pregnant and lactating women
Those who participated in other clinical trials within 30 days prior to participation in this clinical trial and received investigational drugs or received procedures
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
Those who received celecoxib and prednisolone (or methylprednisolone) within 30 days prior to participation in this clinical trial