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
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis
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
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
NCT ID
NCT04885751
First Posted
April 26, 2021
Last Updated
May 7, 2021
Sponsor
Seoul National University Boramae Hospital
Collaborators
Dong-A ST Co., Ltd.
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
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Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy
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