Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-02-26 @ 1:35 PM
Study NCT ID:
NCT03736369
Status:
COMPLETED
Last Update Posted:
2020-09-03
First Post:
2018-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634065', 'term': 'fexuprazan'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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': 263}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2018-10-26', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative healing rate of erosive esophagitis at 8week by endoscopy', 'timeFrame': 'at 8week'}], 'secondaryOutcomes': [{'measure': 'Cumulative healing rate of erosive esophagitis at 4week by endoscopy', 'timeFrame': 'at 4week'}, {'measure': 'Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)', 'timeFrame': 'at 4week and 8week', 'description': 'Mean change of the frequency or severity of main symptoms'}, {'measure': 'Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)', 'timeFrame': 'at 4week and 8week', 'description': 'Mean change of the total score of GERD-HRQL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 20 and 75 years old based on the date of written agreement\n* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy\n* Those who experienced symptoms of heartburn or acid regurgitation within the last 7 days\n\nExclusion Criteria:\n\n* Those who have undergone gastric acid suppression or gastric, esophageal surgery\n* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease'}, 'identificationModule': {'nctId': 'NCT03736369', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'DW_DWP14012301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWP14012 40mg', 'description': 'Orally, once daily', 'interventionNames': ['Drug: DWP14012 40mg', 'Drug: Esomeprazole 40mg placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole 40mg', 'description': 'Orally, once daily', 'interventionNames': ['Drug: DWP14012 40mg placebo', 'Drug: Esomeprazole 40mg']}], 'interventions': [{'name': 'DWP14012 40mg', 'type': 'DRUG', 'description': 'DWP14012 40mg, tablet, orally, once daily for up to 8 weeks', 'armGroupLabels': ['DWP14012 40mg']}, {'name': 'DWP14012 40mg placebo', 'type': 'DRUG', 'description': 'DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks', 'armGroupLabels': ['Esomeprazole 40mg']}, {'name': 'Esomeprazole 40mg', 'type': 'DRUG', 'otherNames': ['Nexium 40mg'], 'description': 'Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks', 'armGroupLabels': ['Esomeprazole 40mg']}, {'name': 'Esomeprazole 40mg placebo', 'type': 'DRUG', 'otherNames': ['Nexium 40mg placebo'], 'description': 'Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks', 'armGroupLabels': ['DWP14012 40mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}