Viewing Study NCT01499368

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Ignite Creation Date: 2025-12-24 @ 5:47 PM
Ignite Modification Date: 2026-02-25 @ 8:18 PM
Study NCT ID: NCT01499368
Status: COMPLETED
Last Update Posted: 2025-01-15
First Post: 2011-12-21
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C076948', 'term': 'lafutidine'}, {'id': 'D015738', 'term': 'Famotidine'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rainbowleo@boryung.co.kr', 'phone': '+82-2-708-8069', 'title': 'Manager of Clinical Research', 'organization': 'Boryung Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '4 week, 8 week and 9 week', 'eventGroups': [{'id': 'EG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po', 'otherNumAtRisk': 165, 'otherNumAffected': 36, 'seriousNumAtRisk': 165, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po', 'otherNumAtRisk': 162, 'otherNumAffected': 30, 'seriousNumAtRisk': 162, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po', 'otherNumAtRisk': 167, 'otherNumAffected': 34, 'seriousNumAtRisk': 167, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breath odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eructation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tinea cruris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Periorbital haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-alcoholic steatohepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mixed incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Basal cell carcinoma', 'notes': 'During the treatment period, he got biopsy at the Dermatology for skin lesion on the left inguinal area, which he had 2 years ago.\n\nThe result was basal cell carcinoma, but the physician judged that causality of this event with the IP was unlikely.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'notes': 'He had musculoskeletal pain because of a car accident, during the treatment period.\n\nThe physician confirmed that this shoulder pain was caused by muscle tears, which he originally had, and judged that causality of this event with IP was unlikely.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'notes': 'Pregnancy After 1 month of the treatment peroid, she dropped out of the trial. About 7 months later, she gave birth to a healthy baby boy.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 165, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recovery Rates of Reflux Esophagitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po'}, {'id': 'OG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po'}, {'id': 'OG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po'}], 'classes': [{'categories': [{'title': 'Recovered', 'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}, {'title': 'Not recovered', 'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority: The Lower limit is not lower than -15%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "The Proportion of Days Without 'Cardinal Symptom'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po'}, {'id': 'OG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po'}, {'id': 'OG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po'}], 'classes': [{'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.64', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '0.56', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.24', 'groupId': 'OG002'}]}]}, {'title': 'week 8(LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Wilcoxon rank sum test', 'nonInferiorityComment': 'Non-Inferiority'}], 'paramType': 'MEAN', 'timeFrame': '4 or 8 week', 'description': "The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain", 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing = Lafutidine(5) , Omeprazole(1)'}, {'type': 'SECONDARY', 'title': "The Proportion of Daytimes Without 'Cardinal Symptom'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po'}, {'id': 'OG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po'}, {'id': 'OG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po'}], 'classes': [{'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.27', 'groupId': 'OG002'}]}]}, {'title': 'week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.20', 'groupId': 'OG002'}]}]}, {'title': 'week 8(LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.28', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 or 8 week', 'description': "The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain", 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing = Lafutidine(5) , Omeprazole(1)'}, {'type': 'SECONDARY', 'title': "The Proportion of Nighttimes Without 'Cardinal Symptom'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po'}, {'id': 'OG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po'}, {'id': 'OG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po'}], 'classes': [{'title': 'week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '0.82', 'spread': '0.23', 'groupId': 'OG002'}]}]}, {'title': 'week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.18', 'groupId': 'OG002'}]}]}, {'title': 'week 8(LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.19', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.29', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 or 8 week', 'description': "The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain", 'unitOfMeasure': 'proportion of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing = Lafutidine(5) , Omeprazole(1)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine 10mg bid, po'}, {'id': 'FG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine 20mg bid, po'}, {'id': 'FG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole 20mg qd(daily), po'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '138'}, {'groupId': 'FG001', 'numSubjects': '145'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '21'}]}], 'dropWithdraws': [{'type': 'Did not meet I/E criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Prohibited Concomitant medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Deviation from visit window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Error of Prescriptions', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}, {'value': '494', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lafutidine', 'description': 'Lafutidine 20mg/day\n\nLafutidine: Lafutidine 20mg/day'}, {'id': 'BG001', 'title': 'Famotidine', 'description': 'Famotidine 40mg/day\n\nFamotidine: Famotidine 40mg/day'}, {'id': 'BG002', 'title': 'Omeprazole', 'description': 'Omeprazole 20mg/day\n\nOmeprazole: Omeprazole 20mg/day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Age, Mean+-STD (years)', 'categories': [{'measurements': [{'value': '50.20', 'spread': '13.57', 'groupId': 'BG000'}, {'value': '51.25', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '49.65', 'spread': '13.84', 'groupId': 'BG002'}, {'value': '50.36', 'spread': '13.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.00', 'groupId': 'BG000', 'lowerLimit': '21.00', 'upperLimit': '73.00'}, {'value': '53.00', 'groupId': 'BG001', 'lowerLimit': '24.00', 'upperLimit': '74.00'}, {'value': '50.00', 'groupId': 'BG002', 'lowerLimit': '20.00', 'upperLimit': '74.00'}, {'value': '52.00', 'groupId': 'BG003', 'lowerLimit': '20.00', 'upperLimit': '74.00'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '20 years~ 29 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '44', 'groupId': 'BG003'}]}]}, {'title': '30 years ~ 39 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}]}]}, {'title': '40 years ~ 49 years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}]}]}, {'title': '50 years ~ 59 years', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '145', 'groupId': 'BG003'}]}]}, {'title': '60 years ~ 69 years', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '113', 'groupId': 'BG003'}]}]}, {'title': '70 years ~ 74 years', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}, {'value': '154', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '340', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Because of a Duplicated subject in Active comparator, One was excluded.'}}, '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': 495}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2011-12-21', 'resultsFirstSubmitDate': '2018-01-16', 'studyFirstSubmitQcDate': '2011-12-22', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-28', 'studyFirstPostDateStruct': {'date': '2011-12-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery Rates of Reflux Esophagitis', 'timeFrame': '8 weeks', 'description': 'Recovery rates of reflux esophagitis on the Esophago Gastro Duodenoscopy test after 8 week treatment-FAS'}], 'secondaryOutcomes': [{'measure': "The Proportion of Days Without 'Cardinal Symptom'", 'timeFrame': '4 or 8 week', 'description': "The proportion of days without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sesation in the chest, Acid reflux, Heartburn including chest pain"}, {'measure': "The Proportion of Daytimes Without 'Cardinal Symptom'", 'timeFrame': '4 or 8 week', 'description': "The proportion of daytimes without 'Cardinal symptom' after 4 or 8 week treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain"}, {'measure': "The Proportion of Nighttimes Without 'Cardinal Symptom'", 'timeFrame': '4 or 8 week', 'description': "The proportion of Nighttimes without 'Cardinal symptom' after 4 or 8 treatment-FAS 'Cardinal symptom': Burning sensation in the chest, Acid reflux, Heartburn including chest pain"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Erosive Esophagitis']}, 'descriptionModule': {'briefSummary': 'To evaluate the healing rate and safety of Lafutidine in erosive esophagitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who had symptoms of heartburn with a diagnosis of grade A to D reflux esophagitis according to the Los Angeles classification\n\nExclusion Criteria:\n\n* Gastric or duodenal ulcers (excluding ulcer scars)\n* Concurrent presence of Barrett's esophagus\n* A history of a poor response to H2RA or PPI given in the recommended dose for 8 weeks\n* Other conditions considered by the attending physician to potentially affect the assessment of efficacy and safety"}, 'identificationModule': {'nctId': 'NCT01499368', 'briefTitle': 'A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boryung Pharmaceutical Co., Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Koran Erosive Esophagitis Patients', 'orgStudyIdInfo': {'id': 'LAF-BR-CT-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lafutidine', 'description': 'Lafutidine 20mg/day', 'interventionNames': ['Drug: Lafutidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Famotidine', 'description': 'Famotidine 40mg/day', 'interventionNames': ['Drug: Famotidine']}, {'type': 'OTHER', 'label': 'Omeprazole', 'description': 'Omeprazole 20mg/day', 'interventionNames': ['Drug: Omeprazole']}], 'interventions': [{'name': 'Lafutidine', 'type': 'DRUG', 'description': 'Lafutidine 20mg/day', 'armGroupLabels': ['Lafutidine']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Famotidine 40mg/day', 'armGroupLabels': ['Famotidine']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Omeprazole 20mg/day', 'armGroupLabels': ['Omeprazole']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sang Woo Lee', 'role': 'STUDY_CHAIR', 'affiliation': 'Korea University Ansan Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boryung Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}