search
Back to results

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

Primary Purpose

Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Eupatilin
Rebamipide
Sponsored by
Seoul National University Boramae Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    eupatilin

    rebamipide

    Arm Description

    take eupatilin to prevent NSAID induced gastroenteropathy

    take rebamipide to prevent NSAID induced gastroenteropathy

    Outcomes

    Primary Outcome Measures

    Percentage of patients with gastric damage
    Percentage of patients with endoscopic Modified Lanza Score >3

    Secondary Outcome Measures

    Change of gastric erosion number
    Change of gastric erosion number at day 56 compared with that at day 0
    Change of Modified Lanza Score
    Change of Modified Lanza Score at day 56 compared with that at day 0
    Change of duodenal erosion number
    Change of duodenal erosion number at day 56 compared with that at day 0
    Gastrointestinal symptom
    Gastrointestinal symptom change using survey at day 56 compared with that at day 0
    Fecal calprotectin
    Fecal calprotectin level change at visit 3 compared with visit 0
    Antioxidant gene expression
    Antioxidant gene expression change at day 56 compared with that at day 0

    Full Information

    First Posted
    April 26, 2021
    Last Updated
    May 7, 2021
    Sponsor
    Seoul National University Boramae Hospital
    Collaborators
    Dong-A ST Co., Ltd.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04885751
    Brief Title
    Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy
    Acronym
    CEERS
    Official Title
    Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy in Patients With NSAIDs and Low Dose Steroid: A Single-center, Randomized, Open Labeled, Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    January 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Boramae Hospital
    Collaborators
    Dong-A ST Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, Other Musculoskeletal Disorder, Gastric Ulcer, Enteritis, NSAID-Associated Gastropathy, NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    eupatilin
    Arm Type
    Experimental
    Arm Description
    take eupatilin to prevent NSAID induced gastroenteropathy
    Arm Title
    rebamipide
    Arm Type
    Active Comparator
    Arm Description
    take rebamipide to prevent NSAID induced gastroenteropathy
    Intervention Type
    Drug
    Intervention Name(s)
    Eupatilin
    Intervention Description
    take eupatilin to prevent NSAID induced gastroenteropathy
    Intervention Type
    Drug
    Intervention Name(s)
    Rebamipide
    Intervention Description
    take rebamipide to prevent NSAID induced gastroenteropathy
    Primary Outcome Measure Information:
    Title
    Percentage of patients with gastric damage
    Description
    Percentage of patients with endoscopic Modified Lanza Score >3
    Time Frame
    evaluated at day 56
    Secondary Outcome Measure Information:
    Title
    Change of gastric erosion number
    Description
    Change of gastric erosion number at day 56 compared with that at day 0
    Time Frame
    evaluated at day 0 and day 56
    Title
    Change of Modified Lanza Score
    Description
    Change of Modified Lanza Score at day 56 compared with that at day 0
    Time Frame
    evaluated at 0 day and day 56
    Title
    Change of duodenal erosion number
    Description
    Change of duodenal erosion number at day 56 compared with that at day 0
    Time Frame
    evaluated at day 0 and day 56
    Title
    Gastrointestinal symptom
    Description
    Gastrointestinal symptom change using survey at day 56 compared with that at day 0
    Time Frame
    evaluated at day 0 and day 56
    Title
    Fecal calprotectin
    Description
    Fecal calprotectin level change at visit 3 compared with visit 0
    Time Frame
    evaluated at day 0 and day 56
    Title
    Antioxidant gene expression
    Description
    Antioxidant gene expression change at day 56 compared with that at day 0
    Time Frame
    evaluated at day 0 and day 56

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Citations:
    PubMed Identifier
    12035587
    Citation
    Sperling RL. NSAIDs. Home Healthc Nurse. 2001 Nov;19(11):687-9. doi: 10.1097/00004045-200111000-00011. No abstract available.
    Results Reference
    background
    PubMed Identifier
    22193214
    Citation
    Conaghan PG. A turbulent decade for NSAIDs: update on current concepts of classification, epidemiology, comparative efficacy, and toxicity. Rheumatol Int. 2012 Jun;32(6):1491-502. doi: 10.1007/s00296-011-2263-6. Epub 2011 Dec 23.
    Results Reference
    background
    PubMed Identifier
    11276797
    Citation
    MacDonald TM. Epidemiology and pharmacoeconomic implications of non-steroidal anti-inflammatory drug-associated gastrointestinal toxicity. Rheumatology (Oxford). 2000 Dec;39 Suppl 2:13-20; discussion 57-9. doi: 10.1093/rheumatology/39.suppl_2.13.
    Results Reference
    background
    PubMed Identifier
    21468265
    Citation
    Lee SH, Han CD, Yang IH, Ha CW. Prescription pattern of NSAIDs and the prevalence of NSAID-induced gastrointestinal risk factors of orthopaedic patients in clinical practice in Korea. J Korean Med Sci. 2011 Apr;26(4):561-7. doi: 10.3346/jkms.2011.26.4.561. Epub 2011 Mar 28.
    Results Reference
    background
    PubMed Identifier
    29847892
    Citation
    Shim KN, Kim JI, Kim N, Kim SG, Jo YJ, Hong SJ, Shin JE, Kim GH, Park KS, Choi SC, Kwon JG, Kim JH, Kim HJ, Kim JW. The efficacy and safety of irsogladine maleate in nonsteroidal anti-inflammatory drug or aspirin-induced peptic ulcer and gastritis. Korean J Intern Med. 2019 Sep;34(5):1008-1021. doi: 10.3904/kjim.2017.370. Epub 2018 Jun 1.
    Results Reference
    background
    Citation
    Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.
    Results Reference
    background
    PubMed Identifier
    17410467
    Citation
    Kim HK, Kim JI, Kim JK, Han JY, Park SH, Choi KY, Chung IS. Preventive effects of rebamipide on NSAID-induced gastric mucosal injury and reduction of gastric mucosal blood flow in healthy volunteers. Dig Dis Sci. 2007 Aug;52(8):1776-82. doi: 10.1007/s10620-006-9367-y. Epub 2007 Apr 5.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs