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Status unknownNCT04885751CEERSUpdated May 13, 2021

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

A Phase 4 interventional study of Eupatilin and Rebamipide in Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis, sponsored by Seoul National University Boramae Hospital. Status unknown. Open to participants aged 19 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-13.

Sponsored by Seoul National University Boramae Hospital · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rheumatoid Arthritis
  • Osteoarthritis
  • Ankylosing Spondylitis
  • Other Musculoskeletal Disorder
  • Gastric Ulcer
  • Enteritis
  • NSAID-Associated Gastropathy
  • NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy
03

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    eupatilin

    take eupatilin to prevent NSAID induced gastroenteropathy

    Drug: Eupatilin

  • Active comparator
    rebamipide

    take rebamipide to prevent NSAID induced gastroenteropathy

    Drug: Rebamipide

Interventions

  • DrugEupatilin

    take eupatilin to prevent NSAID induced gastroenteropathy

  • DrugRebamipide

    take rebamipide to prevent NSAID induced gastroenteropathy

05

What researchers measure

Primary outcomes

  1. Percentage of patients with gastric damage

    Percentage of patients with endoscopic Modified Lanza Score \>3

    Time frame: evaluated at day 56

Secondary outcomes

  1. Change of gastric erosion number

    Change of gastric erosion number at day 56 compared with that at day 0

    Time frame: evaluated at day 0 and day 56

  2. Change of Modified Lanza Score

    Change of Modified Lanza Score at day 56 compared with that at day 0

    Time frame: evaluated at 0 day and day 56

  3. Change of duodenal erosion number

    Change of duodenal erosion number at day 56 compared with that at day 0

    Time frame: evaluated at day 0 and day 56

  4. Gastrointestinal symptom

    Gastrointestinal symptom change using survey at day 56 compared with that at day 0

    Time frame: evaluated at day 0 and day 56

  5. Fecal calprotectin

    Fecal calprotectin level change at visit 3 compared with visit 0

    Time frame: evaluated at day 0 and day 56

  6. Antioxidant gene expression

    Antioxidant gene expression change at day 56 compared with that at day 0

    Time frame: evaluated at day 0 and day 56

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Sperling RL. NSAIDs. Home Healthc Nurse. 2001 Nov;19(11):687-9. doi: 10.1097/00004045-200111000-00011. No abstract available. PubMed 12035587 ↗
  • 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. PubMed 22193214 ↗
  • 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. PubMed 11276797 ↗
  • 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. PubMed 21468265 ↗
  • 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. PubMed 29847892 ↗
  • Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.
  • 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. PubMed 17410467 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT04885751
Lead sponsor
Seoul National University Boramae Hospital
Collaborators
Dong-A ST Co., Ltd.
Responsible party
Hyoun Woo Kang (Associate professor, Seoul National University Boramae Hospital) — Principal investigator
First posted
May 13, 2021
Start date
Jun 1, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Jan 31, 2022 (estimated)
Last update
May 13, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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