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Rheumatoid ArthritisPhase 4CEERSNCT04885751

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

A Phase 4 study testing Eupatilin and Rebamipide in people with Rheumatoid Arthritis and Osteoarthritis, run by Seoul National University Boramae Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
What is being tested?
Eupatilin and Rebamipide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jun 2021to 31 Jan 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 14Show fewer
  • 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

About this study

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

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.

Being tested
Eupatilin, Rebamipide
Medical subject headings
Arthritis, Rheumatoid, Osteoarthritis, Spondylitis, Ankylosing, Stomach Ulcer, Enteritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EupatilinDrug

    take eupatilin to prevent NSAID induced gastroenteropathy

  • RebamipideDrug

    take rebamipide to prevent NSAID induced gastroenteropathy

Study groups in NCT04885751
Study groupRoleWhat they receive
eupatilinExperimentaltake eupatilin to prevent NSAID induced gastroenteropathy
Receives: Drug: Eupatilin
rebamipideActive comparatortake rebamipide to prevent NSAID induced gastroenteropathy
Receives: Drug: Rebamipide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients with gastric damage

    Percentage of patients with endoscopic Modified Lanza Score >3

    Measured: evaluated at day 56

Secondary outcomes (6)

  1. Change of gastric erosion number

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

    Measured: 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

    Measured: 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

    Measured: evaluated at day 0 and day 56

  4. Gastrointestinal symptom

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

    Measured: evaluated at day 0 and day 56

  5. Fecal calprotectin

    Fecal calprotectin level change at visit 3 compared with visit 0

    Measured: evaluated at day 0 and day 56

  6. Antioxidant gene expression

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

    Measured: evaluated at day 0 and day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2021
  2. Study start1 Jun 2021 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Jan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04885751
Sponsor's protocol ID
Eupatilin_GEP_01
Acronym
CEERS
Status last verified
May 2021
First submitted
26 Apr 2021
Last updated
13 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Eupatilin and Rebamipide in people with Rheumatoid Arthritis and Osteoarthritis, run by Seoul National University Boramae Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients with gastric damage (time frame: evaluated at day 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04885751, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.

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