Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2025-12-29 @ 5:02 AM
Study NCT ID:
NCT07115706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-08-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7150}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-08-04', 'studyFirstSubmitQcDate': '2025-08-04', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Reflux Disease Questionnaire (RDQ) at Week 8', 'timeFrame': 'Week 8', 'description': 'This questionnaire is a self-reported instrument designed to assess the main symptoms of gastroesophageal reflux disease (GERD), including heartburn, acid regurgitation, and dyspepsia. It consists of a total of 12 items, each evaluating the frequency and severity of symptoms using a 6-point scale (0 to 5). In this observational study, only heartburn and acid regurgitation symptoms are assessed. The questionnaire is completed by the study participants themselves, and higher total scores indicate more severe symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erosive Gastroesophageal Reflux Disease'], 'conditions': ['Erosive Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of JAQBO® Tab. 20 mg(Zastaprazan citrate) patients who have been prescribed the investigational drug.', 'detailedDescription': 'Multi-center prospective observational study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hospital', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* subjects aged 19 years or older who have been diagnosed with erosive reflux disease (ERD)\n* subjects who have voluntarily decided to participate in this observational study and have provided written informed consent after receiving the study information and consent form\n\nExclusion Criteria:\n\n* Subjects who fall under the contraindications listed in the precautions for use section of the approved labeling for Fexuclu tablets:\n\n 1. Subjects with hypersensitivity or a history of hypersensitivity to the investigational drug or any of its components\n 2. Subjects currently taking medications containing atazanavir, nelfinavir, or rilpivirine\n 3. Pregnant women, women who may be pregnant, or breastfeeding women\n 4. Subjects with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Subjects deemed inappropriate for participation in the study at the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT07115706', 'briefTitle': 'JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive GERD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jeil Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center Prospective Observational Study to Evaluate the Effectiveness and Safety of JAQBO® Tab. 20 mg(Zastaprazan Citrate) in Erosive Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'JL-JAQ-403'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'those with a condition'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Minjeong Kim', 'role': 'CONTACT', 'email': 'mjkim1@jeilpharm.co.kr', 'phone': '+82 2-549-7451', 'phoneExt': '542'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}