Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-28 @ 4:21 AM
Study NCT ID:
NCT03998969
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2019-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of DA-5204 on Gastroesophageal Reflux Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D004942', 'term': 'Esophagitis, Peptic'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'C000711370', 'term': 'DA-5204'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2019-06-25', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopically effective improvement', 'timeFrame': '4 weeks', 'description': 'A percentage of subjects showed effective improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy.\n\nThe definition of "effective improvement" is the subjects showed score changed from 3 to 0, from 2 to 0, or from 3 to 1.\n\n\\[score 0(LA grade N): normal mucosa, score 1(LA grade M): minimal changes to the mucosa such as erythema, blurring and/or whitish turbidity, score 2(LA grade A): non-confluent mucosal breaks \\<5 mm in length, score 3(LA grade B): non-confluent mucosal breaks ≥5 mm in length\\]'}, {'measure': 'Endoscopically complete improvement', 'timeFrame': '4 weeks', 'description': 'A percentage of subjects showed complete improvement of erosive esophagitis (esophageal mucosal injury) by the endoscopy.\n\nThe definition of "complete improvement" is the subjects showed score changed from 3 to 0 or from 2 to 0.'}], 'secondaryOutcomes': [{'measure': 'Symptom improvement', 'timeFrame': '4 weeks', 'description': 'A percentage of subjects showed sufficient improvement of reflux symptom score from Gastroesophageal Reflux Disease Questionnaire (GerdQ).\n\nThe definition of "sufficient improvement" is the subjects showed ≥50% reduction from the initial sum of scores for GerdQ.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux', 'Esophagitis, Peptic'], 'conditions': ['Esophageal Disease']}, 'descriptionModule': {'briefSummary': 'This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.', 'detailedDescription': 'Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus causes troublesome symptoms, such as heartburn and acid regurgitation.\n\nProton pump inhibitors, as acid suppressor, are the agents recommended as the first-line treatment for gastroesophageal reflux disease. However, approximately 20-30% of patients have insufficient effect on this therapy alone.\n\nDA-5204 is a medicine based on Artemisia asiatica 95% ethanol extract. DA-5204 has been administered to treat gastritis and gastric ulcers with antioxidative and cytoprotective actions on gastric mucosal damage. Therefore, we expect DA-5204 to be effective in reflux esophagitis (esophageal mucosal injury).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age is over 20 years old, under 75 years old, men or women\n* Patients diagnosed with erosive esophagitis by gastroscopy\n* Signed the informed consent forms\n\nExclusion Criteria:\n\n* Patients who is impossible to receive gastroscopy\n* Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding\n* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks\n* Patients with surgery related to gastroesophageal\n* Patients with Zollinger-Ellison syndrome\n* Patients with any kind of malignant tumor\n* Patients administered with anti-thrombotic drugs\n* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease\n* Patients with neuropsychiatric disorder, alcoholism, or drug abuse\n* Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.\n* Women either pregnant or breast feeding"}, 'identificationModule': {'nctId': 'NCT03998969', 'briefTitle': 'Efficacy of DA-5204 on Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy of DA-5204 (Stillen 2X®) for Patients With Gastroesophageal Reflux Disease: A Randomized, Double-blind, Placebo-controlled Pilot Study', 'orgStudyIdInfo': {'id': 'SNUBH-DHLDA5204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pantoprazole and DA-5204', 'description': "Pantoprazole 40mg once daily and 'DA-5204' twice daily by mouth, administered for 4 weeks", 'interventionNames': ['Drug: Pantoprazole', 'Drug: DA-5204']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pantoprazole and placebo', 'description': "Pantoprazole 40mg once daily and 'placebo' twice daily by mouth, administered for 4 weeks", 'interventionNames': ['Drug: Pantoprazole', 'Drug: Placebo']}], 'interventions': [{'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['Pantoline'], 'description': 'Pantoprazole 40mg tablet', 'armGroupLabels': ['Pantoprazole and DA-5204', 'Pantoprazole and placebo']}, {'name': 'DA-5204', 'type': 'DRUG', 'otherNames': ['Stillen 2X®'], 'description': 'DA-5204 tablet', 'armGroupLabels': ['Pantoprazole and DA-5204']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo (for DA-5204)'], 'description': 'Film-coated tablet manufactured to mimic DA-5204', 'armGroupLabels': ['Pantoprazole and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bungdang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Dong Ho Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Clinical Research', 'investigatorFullName': 'Dong Ho Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}