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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis Other Musculoskeletal Disorder Gastric Ulcer Enteritis NSAID-Associated Gastropathy NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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eupatilin

take eupatilin to prevent NSAID induced gastroenteropathy

Group Type EXPERIMENTAL

Eupatilin

Intervention Type DRUG

take eupatilin to prevent NSAID induced gastroenteropathy

rebamipide

take rebamipide to prevent NSAID induced gastroenteropathy

Group Type ACTIVE_COMPARATOR

Rebamipide

Intervention Type DRUG

take rebamipide to prevent NSAID induced gastroenteropathy

Interventions

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Eupatilin

take eupatilin to prevent NSAID induced gastroenteropathy

Intervention Type DRUG

Rebamipide

take rebamipide to prevent NSAID induced gastroenteropathy

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes