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Ignite Creation Date: 2025-12-25 @ 2:08 AM

Ignite Modification Date: 2026-01-04 @ 8:01 PM

Study NCT ID: NCT02085460

Status: COMPLETED

Last Update Posted: 2021-10-18

First Post: 2014-03-11

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events were collected from start of the study drug administration up to Day 85', 'description': 'Safety set comprised those who received the study drug or placebo at least once and whose safety data were collected at least once after beginning the treatment.', 'eventGroups': [{'id': 'EG000', 'title': '2% Rebamipide Liquid', 'description': '6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': '4% Rebamipide Liquid', 'description': '6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 32, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Placebo', 'description': '6 times daily (The treatment started 3 days prior to the initiation of chemoradiotherapy and continued for another 77 days.)', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hearing impaired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Vessel puncture site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Wound complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Hyperuricaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 18.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 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[{'title': 'Japan', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set comprised patients who received the study drug or placebo at least once and whose efficacy data were collected immediately after beginning the treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 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To evaluate the severity of oral mucositis objectively, the clinical findings of the oral mucosa as well as functional disorders and symptomatic aspects were recorded in the Oral Mucositis Assessment Sheet by each investigator. Photographic documentation of the oral mucosa was also submitted by each investigator, 3 days before or 57 days after initiation of chemoradiotherapy, or at the time of withdrawal. The Oral Mucositis Assessment Sheets and photographic documentation were then reviewed by the Oral Mucositis Evaluation Committee to grade the severity of oral mucositis according to the CTCAE 3.0.z'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Who Did Not Developed Grade ≥3 Mucositis', 'timeFrame': 'Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77', 'description': 'Day 1 was defined as the start of chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '30426268', 'type': 'BACKGROUND', 'citation': 'Ueno T, Zenda S, Konishi T, Yurikusa T, Shibasaki Y, Nagamoto H, Fujii M. The post hoc analysis comparing the severity grades of chemoradiotherapy-induced oral mucositis scored between the central and local assessors in a multicenter, randomized controlled trial of rebamipide for head and neck cancer. Int J Clin Oncol. 2019 Mar;24(3):241-247. doi: 10.1007/s10147-018-1355-7. Epub 2018 Nov 13.'}, {'pmid': '28476132', 'type': 'DERIVED', 'citation': 'Yokota T, Ogawa T, Takahashi S, Okami K, Fujii T, Tanaka K, Iwae S, Ota I, Ueda T, Monden N, Matsuura K, Kojima H, Ueda S, Sasaki K, Fujimoto Y, Hasegawa Y, Beppu T, Nishimori H, Hirano S, Naka Y, Matsushima Y, Fujii M, Tahara M. Efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer: a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II study. BMC Cancer. 2017 May 5;17(1):314. doi: 10.1186/s12885-017-3295-4.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.\n* Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.\n\n 1. Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx\n 2. Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx\n* Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer\n* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n* Patients who are able to hold fluid in the mouth\n* Patients who are able to swallow the investigational medicinal product (IMP)\n* Patients expected to survive for at least 3 months\n* Patients who have given written informed consent in person\n* Patients who can stay at or visit the hospital for scheduled examinations and observations\n* Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration\n\nExclusion Criteria:\n\n* Patients with primary malignant tumors other than head and neck cancer.\n* Patients with symptomatic viral, bacterial, or fungal infection\n* Patients with serious renal impairment\n* Patients with distant metastasis\n* Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)\n* Patients with any of the following laboratory test results:\n\n 1. Neutrophil count: \\<1500 L\n 2. Platelet count: \\<75000 L\n 3. Hemoglobin: \\<10.0 g/L\n 4. Aspartate aminotransferase (AST): \\>3 times the upper limit of the reference value at the trial site\n 5. Alanine aminotransferase (ALT): \\>3 times the upper limit of the reference value at the trial site\n 6. Serum bilirubin: \\>1.5 times the upper limit of the reference value at the trial site\n 7. Serum albumin: \\<3.0 g/dL\n 8. Serum creatinine: \\>1.5 the upper limit of the reference value at the trial site\n 9. Creatinine clearance : \\<30 mL/min\n* Patients complicated with autoimmune disease\n* Patients requiring continuous systemic administration of glucocorticoid\n* Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant\n* Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy\n* Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds\n* Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial'}, 'identificationModule': {'nctId': 'NCT02085460', 'briefTitle': 'A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer', 'orgStudyIdInfo': {'id': '037-12-001'}, 'secondaryIdInfos': [{'id': 'JapicCTI-142467', 'type': 'OTHER', 'domain': 'Japic'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '6 times daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2% Rebamipide liquid', 'description': '6 times daily', 'interventionNames': ['Drug: 2% Rebamipide liquid']}, {'type': 'EXPERIMENTAL', 'label': '4% Rebamipide liquid', 'description': '6 times daily', 'interventionNames': ['Drug: 4% Rebamipide liquid']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}, {'name': '2% Rebamipide liquid', 'type': 'DRUG', 'armGroupLabels': ['2% Rebamipide liquid']}, {'name': '4% Rebamipide liquid', 'type': 'DRUG', 'armGroupLabels': ['4% Rebamipide liquid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chubu Region', 'country': 'Japan'}, {'city': 'Chugoku Region', 'country': 'Japan'}, {'city': 'Kanto Region', 'country': 'Japan'}, {'city': 'Kinki Region', 'country': 'Japan'}, {'city': 'Tohoku Region', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Jun-ichi Hashimoto, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}