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

NCT04885751 | Unknown Phase 4

• 1 other identifier: Eupatilin_GEP_01
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with gastric damage

  Percentage of patients with endoscopic Modified Lanza Score \>3

  evaluated at day 56

Secondary Outcomes (6)

• Change of gastric erosion number

  evaluated at day 0 and day 56

• Change of Modified Lanza Score

  evaluated at 0 day and day 56

• Change of duodenal erosion number

  evaluated at day 0 and day 56

• Gastrointestinal symptom

  evaluated at day 0 and day 56

• Fecal calprotectin

  evaluated at day 0 and day 56

Study Arms (2)

eupatilin

EXPERIMENTAL

take eupatilin to prevent NSAID induced gastroenteropathy

Drug: Eupatilin

rebamipide

ACTIVE COMPARATOR

take rebamipide to prevent NSAID induced gastroenteropathy

Drug: Rebamipide

Interventions

Eupatilin DRUG

take eupatilin to prevent NSAID induced gastroenteropathy

eupatilin

Rebamipide DRUG

take rebamipide to prevent NSAID induced gastroenteropathy

rebamipide

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Boramae Hospital: lead
• Dong-A ST Co., Ltd.: collaborator

Related Publications (7)

• Sperling RL. NSAIDs. Home Healthc Nurse. 2001 Nov;19(11):687-9. doi: 10.1097/00004045-200111000-00011. No abstract available.

  PMID: 12035587 BACKGROUND

• 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.

  PMID: 22193214 BACKGROUND

• 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.

  PMID: 11276797 BACKGROUND

• 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.

  PMID: 21468265 BACKGROUND

• 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.

  PMID: 29847892 BACKGROUND

• Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.

  BACKGROUND

• 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.

  PMID: 17410467 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteoarthritis; Spondylitis, Ankylosing; Stomach Ulcer; Enteritis

Interventions

eupatilin; rebamipide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastroenteritis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 13, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE