Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT05886933
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2023-05-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9846}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-22', 'studyFirstSubmitDate': '2023-05-24', 'studyFirstSubmitQcDate': '2023-05-24', 'lastUpdatePostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the average score of the degree of individual symptoms of subjective symptoms (RDQ)', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Average score change in Reflux Disease Questionnaire (0 \\~5) from baseline'}, {'measure': 'Change in the average score of the frequency of individual symptoms of subjective symptoms (RDQ)', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Average score change in Reflux Disease Questionnaire (0 \\~5) from baseline'}], 'secondaryOutcomes': [{'measure': 'Changes in average score of the degree by symptoms (reflux, heartburn, indigestion)', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Average score change in Reflux Disease Questionnaire (0 \\~5) from baseline'}, {'measure': 'Changes in average score of the frequency by symptoms (reflux, heartburn, indigestion)', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Average score change in Reflux Disease Questionnaire (0 \\~5) from baseline'}, {'measure': 'RDQ validity rate', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'RDQ validity rate at 4 weeks(up to 8 weeks) from baseline'}, {'measure': 'RDQ loss rate', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'RDQ loss rate at 4 weeks(up to 8 weeks) from baseline'}, {'measure': 'Overall improvement evaluated by the subjects', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Overall improvement result (scale 1\\~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the subjects at 4 weeks(up to 8 weeks) from baseline'}, {'measure': 'Overall improvement evaluated by the researchers', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Overall improvement result (scale 1\\~5, Fully recovered/Much improvement/Moderate improvement/Unchanged/Aggravated) evaluated by the researchers at 4 weeks(up to 8 weeks) from baseline'}, {'measure': 'Quality of Life (GERD-HRQL) Total score change', 'timeFrame': 'at least 4 weeks (up to 8 weeks)', 'description': 'Quality of Life (GERD-HRQL) Total score change at 4 weeks(up to 8 weeks) from baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'This observational study is a large-scale, prospective, and multi-institutional observational study.\n\nPatients from 19 to 75 years of age, will take a self-assessment (PRO) during the study period before and after administration of Pexuclue tablet.', 'detailedDescription': "Data will be collected based on patient's medical records from daily visit. Enrolled subjects will take a Patient Reported Outcome (PRO) survey including Quality of life evaluation (GERD-HRQL) and self-awareness symptom (RDQ).\n\nThe survey will be done twice (before and after the administration of Fexuclue tablet) electronically through an application (e-PRO)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Referring to the minimum number of subjects required and the number of patients with gastroesophageal reflux disease in Korea, We expected to recruit about 16,000 people which is 0.2 %.\n\nHowever, since this study is conducted under daily medical care, we expected 10% to be dropout rate.\n\nTherefore the total study population is about 18,000', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult aged 19 years to 75 years (on registration date)\n2. Patient scheduled to administer Fexuclue tablet based on the medical judgment of investigator.\n3. Patient who has not taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.\n4. Patient who agreed to participate in this observation study and signed Informed Consent Form\n\nExclusion Criteria:\n\n1. A person who falls under the prohibition of administration according to the permission for Fexuclue Tablet\n\n * Patients with hypersensitivity to the components of Fexuclue tablet or Fexuclue tablet and a history thereof\n * Patients undergoing Atazanavir, Nelfinavir or Lilpivirin-containing preparations\n * Pregnant and lactating women\n * Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabortion\n2. A person who has taken a treatment for gastroesophageal reflux disease within two weeks from baseline visit.\n3. In addition to the above, a person who has determined that the researcher (the doctor in charge) is not suitable for participation in this observation study'}, 'identificationModule': {'nctId': 'NCT05886933', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Prospective, Non-Intervention, Multi-Center Observational Study to Evaluate the Efficacy and Safety of FEXUCLUE Tablet in Patients With Erosive Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': 'DWFE_P407'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fexuprazan Hydrochloride', 'type': 'DRUG', 'otherNames': ['Fexuclue Tablet'], 'description': 'Patient treated with Fexuprazan Hydrochloride (Fexuclue Tablet)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Busan', 'country': 'South Korea', 'facility': 'Co&Ping Otolaryngology Clinic', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Homin Lee', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Co&Ping Otolaryngology Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Undecided at this point'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}