Ignite Creation Date:
2025-12-24 @ 1:58 PM
Ignite Modification Date:
2026-01-01 @ 12:31 AM
Study NCT ID:
NCT04613895
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Effect According to Timing of Administration of DWP14012 40 mg
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000634065', 'term': 'fexuprazan'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 186}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-17', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-28', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'healing rate at 4 week', 'timeFrame': '4 week', 'description': 'Cumulative healing rate of erosive esophagitis at 4 week by endoscopy'}], 'secondaryOutcomes': [{'measure': 'healing rate at 2 week', 'timeFrame': '2 week', 'description': 'Cumulative healing rate of erosive esophagitis at 2 week by endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to establish noninferiority of efficacy of DWP14012 (40 mg once daily) based on Timing of Administration.', 'detailedDescription': 'Subjects will provide written informed consent for study participation and then undergo appropriate screening. Subjects who meet the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to either before meal group or after meal group. Subjects will be stratified into two groups according to Los Angeles classification grades (LA grades) A/B or C/D, as determined by upper gastrointestinal (GI) endoscopy. Subjects will visit the site at Week 2 for endoscopic assessment. Subjects whose mucosal breaks have completely healed will be prematurely withdrawn and considered to have reached end of treatment. Subjects whose mucosal breaks have not healed will continue to receive IPs for an additional 2 weeks and will visit the site for endoscopic assessment at Week 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 19 and 75 years old based on the date of written agreement\n* Those who have been diagnosed with erosive esophagitis 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': 'NCT04613895', 'briefTitle': 'Treatment Effect According to Timing of Administration of DWP14012 40 mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-Center, Open-label, Randomized Trial to Evaluate the Efficacy and Safety Based on Timing of Administration of DWP14012 in Patients With Erosive Esophagitis', 'orgStudyIdInfo': {'id': 'IIT_DWP14012001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'fed state group', 'description': 'just after a meal', 'interventionNames': ['Drug: DWP14012']}, {'type': 'EXPERIMENTAL', 'label': 'fasted state group', 'description': 'before a meal', 'interventionNames': ['Drug: DWP14012']}], 'interventions': [{'name': 'DWP14012', 'type': 'DRUG', 'otherNames': ['fed state'], 'description': 'DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks', 'armGroupLabels': ['fed state group']}, {'name': 'DWP14012', 'type': 'DRUG', 'otherNames': ['fasted state'], 'description': 'DWP14012 40 mg, orally, once daily before a meal up to 4 weeks', 'armGroupLabels': ['fasted state group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04763', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'HOJIN LEE', 'role': 'CONTACT', 'email': 'hjlee200@daewoong.co.kr', 'phone': '+82-2-550-8651'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hanyang University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}