Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT04885751
Status:
UNKNOWN
Last Update Posted:
2021-05-13
First Post:
2021-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}, {'id': 'D013276', 'term': 'Stomach Ulcer'}, {'id': 'D004751', 'term': 'Enteritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D000844', 'term': 'Ankylosis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045325', 'term': 'eupatilin'}, {'id': 'C052785', 'term': 'rebamipide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2021-04-26', 'studyFirstSubmitQcDate': '2021-05-07', 'lastUpdatePostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with gastric damage', 'timeFrame': 'evaluated at day 56', 'description': 'Percentage of patients with endoscopic Modified Lanza Score \\>3'}], 'secondaryOutcomes': [{'measure': 'Change of gastric erosion number', 'timeFrame': 'evaluated at day 0 and day 56', 'description': 'Change of gastric erosion number at day 56 compared with that at day 0'}, {'measure': 'Change of Modified Lanza Score', 'timeFrame': 'evaluated at 0 day and day 56', 'description': 'Change of Modified Lanza Score at day 56 compared with that at day 0'}, {'measure': 'Change of duodenal erosion number', 'timeFrame': 'evaluated at day 0 and day 56', 'description': 'Change of duodenal erosion number at day 56 compared with that at day 0'}, {'measure': 'Gastrointestinal symptom', 'timeFrame': 'evaluated at day 0 and day 56', 'description': 'Gastrointestinal symptom change using survey at day 56 compared with that at day 0'}, {'measure': 'Fecal calprotectin', 'timeFrame': 'evaluated at day 0 and day 56', 'description': 'Fecal calprotectin level change at visit 3 compared with visit 0'}, {'measure': 'Antioxidant gene expression', 'timeFrame': 'evaluated at day 0 and day 56', 'description': 'Antioxidant gene expression change at day 56 compared with that at day 0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Osteoarthritis', 'Ankylosing Spondylitis', 'Other Musculoskeletal Disorder', 'Gastric Ulcer', 'Enteritis', 'NSAID-Associated Gastropathy', 'NSAID (Non-Steroidal Anti-Inflammatory Drug) Induced Enteropathy']}, 'referencesModule': {'references': [{'pmid': '12035587', 'type': 'BACKGROUND', 'citation': 'Sperling RL. NSAIDs. Home Healthc Nurse. 2001 Nov;19(11):687-9. doi: 10.1097/00004045-200111000-00011. No abstract available.'}, {'pmid': '22193214', 'type': 'BACKGROUND', '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.'}, {'pmid': '11276797', 'type': 'BACKGROUND', '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.'}, {'pmid': '21468265', 'type': 'BACKGROUND', '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.'}, {'pmid': '29847892', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', 'citation': 'Julious S. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.'}, {'pmid': '17410467', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and women who were adults at the time of receipt of written consent (age 19-70)\n2. 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.\n3. At screening (before baseline) endoscopy results Modified Lanza Score (MLS) 0\\~2\n4. Those who have not had severe gastrointestinal symptoms in the previous 3 months\\[Excluding mild abdominal distention, abdominal pain, diarrhea, dyspepsia, nausea, and vomiting\\]\n5. A person who agrees to participate in this clinical trial and voluntarily signs a written consent form\n\nExclusion Criteria:\n\n1. Those with a history of gastrointestinal surgery (excluding appendectomy)\n2. 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\n3. 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.\n4. Those with a history of recurrent gastrointestinal ulcer/perforation\n5. Those with cerebrovascular bleeding or confirmed systemic bleeding disorder\n6. Persons with severe uncontrolled heart failure (NYHA Class III-IV), high blood pressure (above 160/100 mmHg)\n7. Those who have plans for surgical operation during the clinical trial period\n8. Persons with a history of chronic pancreatitis, chronic renal diseases, chronic liver diseases, or other serious comorbid diseases\n9. Those with clinically significant abnormal values (AST, ALT, BUN, Cr exceeding 2.5 times or Hb\\<10g/dL) by laboratory examination\n10. Those with a history of alcohol or drug abuse/dependence\n11. Pregnant and lactating women\n12. Those who participated in other clinical trials within 30 days prior to participation in this clinical trial and received investigational drugs or received procedures\n13. 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\n14. Those who received celecoxib and prednisolone (or methylprednisolone) within 30 days prior to participation in this clinical trial"}, 'identificationModule': {'nctId': 'NCT04885751', 'acronym': 'CEERS', 'briefTitle': 'Compare the Effect of Eupatilin and Rebamipide on the Prevention of Gastroenteropathy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Boramae Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'Eupatilin_GEP_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eupatilin', 'description': 'take eupatilin to prevent NSAID induced gastroenteropathy', 'interventionNames': ['Drug: Eupatilin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rebamipide', 'description': 'take rebamipide to prevent NSAID induced gastroenteropathy', 'interventionNames': ['Drug: Rebamipide']}], 'interventions': [{'name': 'Eupatilin', 'type': 'DRUG', 'description': 'take eupatilin to prevent NSAID induced gastroenteropathy', 'armGroupLabels': ['eupatilin']}, {'name': 'Rebamipide', 'type': 'DRUG', 'description': 'take rebamipide to prevent NSAID induced gastroenteropathy', 'armGroupLabels': ['rebamipide']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Boramae Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hyoun Woo Kang', 'investigatorAffiliation': 'Seoul National University Boramae Hospital'}}}}