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

Sponsor
Seoul National University Boramae Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04885751
Collaborator
Dong-A ST Co., Ltd. (Industry)
50
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: eupatilin

take eupatilin to prevent NSAID induced gastroenteropathy

Drug: Eupatilin
take eupatilin to prevent NSAID induced gastroenteropathy
Active Comparator: rebamipide

take rebamipide to prevent NSAID induced gastroenteropathy

Drug: Rebamipide
take rebamipide to prevent NSAID induced gastroenteropathy

Outcome Measures

Primary Outcome Measures

  1. Percentage of patients with gastric damage [evaluated at day 56]

    Percentage of patients with endoscopic Modified Lanza Score >3

Secondary Outcome Measures

  1. Change of gastric erosion number [evaluated at day 0 and day 56]

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

  2. Change of Modified Lanza Score [evaluated at 0 day and day 56]

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

  3. Change of duodenal erosion number [evaluated at day 0 and day 56]

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

  4. Gastrointestinal symptom [evaluated at day 0 and day 56]

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

  5. Fecal calprotectin [evaluated at day 0 and day 56]

    Fecal calprotectin level change at visit 3 compared with visit 0

  6. Antioxidant gene expression [evaluated at day 0 and day 56]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
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:

  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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hyoun Woo Kang, Associate professor, Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier:
NCT04885751
Other Study ID Numbers:
  • Eupatilin_GEP_01
First Posted:
May 13, 2021
Last Update Posted:
May 13, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Musculoskeletal Diseases
Stomach Ulcer
Enteritis
Rebamipide

Study Results

No Results Posted as of May 13, 2021