Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 7:01 PM
Study NCT ID:
NCT01658020
Status:
COMPLETED
Last Update Posted:
2014-10-13
First Post:
2012-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C480202', 'term': 'zabofloxacin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ymoh55@amc.seoul.kr', 'phone': '+82-2-3010-3136', 'title': 'Principal Investigator', 'organization': 'Asan Midical Center'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': True, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'About 1.5 years', 'eventGroups': [{'id': 'EG000', 'title': 'DW224', 'description': 'Zabofloxacin Tablet 400mg given by oral administration\n\nMoxifloxacin Tablet 400mg: multiple-dose', 'otherNumAtRisk': 175, 'otherNumAffected': 17, 'seriousNumAtRisk': 175, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Avelox', 'description': 'Moxifloxacin Tablet 400mg given by oral administration\n\nZabofloxacin Tablet 400mg: multiple-dose', 'otherNumAtRisk': 167, 'otherNumAffected': 16, 'seriousNumAtRisk': 167, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vimiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Epigastric discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'COPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Sputum retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Face oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Red blood cell microcytes present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 175, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 167, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Response in the Clinical Populations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '86.71', 'groupId': 'OG000', 'lowerLimit': '81.15', 'upperLimit': '92.28'}, {'value': '86.26', 'groupId': 'OG001', 'lowerLimit': '80.36', 'upperLimit': '92.16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10days', 'description': 'Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Clinical Response in the Clinical Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '76.22', 'groupId': 'OG000', 'lowerLimit': '69.25', 'upperLimit': '83.20'}, {'value': '70.99', 'groupId': 'OG001', 'lowerLimit': '63.22', 'upperLimit': '78.76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '36days', 'description': 'Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Clinical Cure Rate in the Microbiological Per Protocol(PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '88.37', 'groupId': 'OG000', 'lowerLimit': '78.79', 'upperLimit': '97.95'}, {'value': '94.87', 'groupId': 'OG001', 'lowerLimit': '87.95', 'upperLimit': '100.00'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10days', 'description': 'Clinical response corresponding clinical cure in the microbiological per-protocol population.\n\nMicrobiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval'}, {'type': 'SECONDARY', 'title': 'Microbiological Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '67.44', 'groupId': 'OG000', 'lowerLimit': '53.44', 'upperLimit': '81.45'}, {'value': '79.49', 'groupId': 'OG001', 'lowerLimit': '66.81', 'upperLimit': '92.16'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '10days', 'description': 'Microbiological response rate in the microbiological per protocol(PP) population.\n\nMicrobiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval'}, {'type': 'SECONDARY', 'title': 'Change in EXACT-PRO Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.90', 'spread': '9.59', 'groupId': 'OG000'}, {'value': '-4.29', 'spread': '9.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.\n\nEXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.\n\nEXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Per protocol population'}, {'type': 'SECONDARY', 'title': 'Change in CAT Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days'}, {'id': 'OG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.46', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '-2.48', 'spread': '5.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 days', 'description': 'The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.\n\nCAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.\n\nCAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.\n\nThe scores of each question item were summed into the total score, which had values between 0 and 40.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'populationDescription': 'Per protocol population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DW224', 'description': 'Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily'}, {'id': 'FG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '175'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '158'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '175', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days'}, {'id': 'BG001', 'title': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.76', 'spread': '7.79', 'groupId': 'BG000'}, {'value': '68.40', 'spread': '8.04', 'groupId': 'BG001'}, {'value': '68.07', 'spread': '7.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '312', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '175', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-02', 'studyFirstSubmitDate': '2012-07-25', 'resultsFirstSubmitDate': '2014-09-01', 'studyFirstSubmitQcDate': '2012-08-01', 'lastUpdatePostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-11', 'studyFirstPostDateStruct': {'date': '2012-08-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response in the Clinical Populations', 'timeFrame': '10days', 'description': 'Clinical response corresponding clinical cure at Test of Cure visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.'}], 'secondaryOutcomes': [{'measure': 'Clinical Response in the Clinical Population', 'timeFrame': '36days', 'description': 'Clinical response corresponding clinical cure at End of Study visit. Based on the clinical outcomes, the results of assessment were classified into Clinical Cure, Clinical Failure, Relapse and Indeterminate.'}, {'measure': 'Clinical Cure Rate in the Microbiological Per Protocol(PP) Population', 'timeFrame': '10days', 'description': 'Clinical response corresponding clinical cure in the microbiological per-protocol population.\n\nMicrobiological responses were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.'}, {'measure': 'Microbiological Response Rate', 'timeFrame': '10days', 'description': 'Microbiological response rate in the microbiological per protocol(PP) population.\n\nMicrobiological rate were discriminated for the pathogens isolated from the respiratory secretion samples of subjects.'}, {'measure': 'Change in EXACT-PRO Score', 'timeFrame': '10 days', 'description': 'The outcome measurement is Change in EXACT-PRO score for clinical populations at Test of cure visit.\n\nEXACT-PRO means that the questionnaires for Exacerbation of Chronic Pulmonary Disease Tool-Patient Reported Outcome of United BioSource Corporation(UBC) of USA that had been standardized, equipped with reliability and feasibility applicable to various COPD patients groups were used in order to quantitate frequency, severity and duration of acute exacerbation as a tool to measure acute exacerbation of COPD.\n\nEXACT-PRO is consisted of 14 questionnaire items were classified into 3 domains, Respiratory Distress Domain, Cough/Sputum Domain, and Chest Symptoms Domain. The Scores of each domain were to be summed into the domain raw summed score or converted into EXACT domain score according to the conversion table. The total score had value in the range from 0 to 100 and higher the value was, severer the respiratory symptoms were in evaluation.'}, {'measure': 'Change in CAT Scores', 'timeFrame': '10 days', 'description': 'The outcome measurement is Change in CAT scores for clinical populations at Test of cure visit.\n\nCAT score means that COPD Assessment Test was used as a tool to assess the effects of COPD on physical, mental status and daily life.\n\nCAT is consisted of 8 items in total and each question item was scored from 0 point to 5 point.\n\nThe scores of each question item were summed into the total score, which had values between 0 and 40.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute exacerbation of Chronic obstructive pulmonary disease', 'Acute Exacerbation', 'Chronic obstructive pulmonary disease(COPD)', 'Zabofloxacin', 'Moxifloxacin'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '31920016', 'type': 'DERIVED', 'citation': 'Yoon S, Kim TE, Kim TH, Na JO, Shin KC, Rhee CK, Jung SS, Choe KH, Yoo KH. Clinical Role of the Chronic Obstructive Pulmonary Disease Assessment Test in Prediction of the Response to Treatment for Exacerbations. J Korean Med Sci. 2020 Jan 13;35(2):e10. doi: 10.3346/jkms.2020.35.e10.'}], 'seeAlsoLinks': [{'url': 'http://medical.amc.seoul.kr/medservice/main/main.do', 'label': 'Asan Medical Center'}, {'url': 'http://www.dong-wha.co.kr/dw_main.asp', 'label': 'Dong Wha Pharm. Co. Ltd.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to Evaluate the Efficacy and Safety Profiles of oral multiple dose of Zabofloxacin Tablet 400 mg.', 'detailedDescription': 'A Phase 3, Multicenter, Double Blind, Active Controlled, Randomized Study to Evaluate the Efficacy and Safety of Zabofloxacin for Patients with acute bacterial exacerbation of Chronic obstructive pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male or female same or older than age of 40\n* Severity of acute exacerbation of Chronic obstructive pulmonary disease(COPD) must suit oral administration treatment\n* Diagnosed as COPD before receiving written informed consent and outcome measure of spirometry testing confirmed as \\[Ratio of Forced Expiratory Volume in 1 second(FEV1) to Forced Vital Capacity(FVC)\\](FEV1/FVC) \\< 0.7\n* Subject showing following signs and symptoms:\n\n (i)Purulent Sputum or Sputum level is increased (ii)Difficulty in breathing is increased\n* Female subjects who might be pregnant must do pregnancy test and results should be negative before randomization is done. She must receive written informed consent form (NOTE: Subject who has used single hormone contraception for pregnancy control or has not been more than 1 year after Tubule ligation and menopause are excluded from the study)\n* Subject who can agree and sign written informed consent form approved by Institutional Review Board(IRB) before participating in study and follow study requirements\n\nExclusion Criteria:\n\n* Subject who administered excess daily dose of antimicrobial/antibiotics in past 72 hours before receiving written consent\n* Diagnosed to have pneumonia by taking chest X-ray in past 48 hours before receiving written consent\n* Diagnosed to have infectious diseases or such diseases results in complications before receiving written consent (NOTE: Septic shock, Bronchiectasis, Lung abscess, Pneumonia, Active tuberculosis, Pulmonary malignancy, Cystic fibrosis, Empyema, Asthma)\n* Have kidney or liver diseases who correspond following criteria:\n\n (i) Creatinine Clearance(CCr) \\< 50 mL/min (ii) Blood Urea Nitrogen(BUN) ≥ 30 mg/dl (iii) Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \\> 3 x Upper Limit Normal(ULN) (iv) Total bilirubin \\> 2 x ULN (v) Alkaline Phosphatase(ALP) \\> 2 x ULN.\n* Organic gastrointestinal disorder having abnormal absorption problem condition in past 6 months before receiving written consent (NOTE: Active Crohn's disease, active ulcerative colitis)\n* Diagnosed to have neutropenia where absolute neutrophil count is \\< 1,000cells/mm3 (NOTE: Even though subject neutrophil count is \\< 1,000cells/mm3, if it is acute infection, subject maybe possible to participate)\n* Chronic Hepatitis B carrier\n* Have proof that subject is Hepatitis C carrier or have Hepatitis C antibody\n* Immunodeficiency diseases such as HIV positive, AIDS, Bone marrow transplant or leukemia\n* Have medical history of hypersensitive reaction to antibiotics of fluoroquinolones\n* Have medical history of seizure or administration of anti-seizure drug in past 1 year before receiving written consent (NOTE: Epilepsy, Convulsions, Myasthenia gravis)\n* Medical history of ventricular arrhythmia\n* Medical history of QTc prolongation or currently administering drug that delays QTc interval (NOTE: QTc prolongation means QTc interval \\> 450 msec)\n* Complex infections or diseases that can effect study assessment or need long-term antibiotic treatment exceeding 7 days\n* Subject who has participated in Clinical trials or Bioequivalence test in past 30 days before receiving written consent\n* Clinically significant by observations considered as unsuitable based on medical judgement by investigators where current condition can effect quality of safety or data"}, 'identificationModule': {'nctId': 'NCT01658020', 'acronym': 'DW224-III-3', 'briefTitle': 'A Study to Evaluate Efficacy and Safety Profile of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong Wha Pharmaceutical Co. Ltd.'}, 'officialTitle': 'Clinical Trials to Evaluate Efficacy and Safety of Zabofloxacin Tablet 400mg and Moxifloxacin Tablet 400mg After Multi-dose Oral Administration in Patients With Acute Bacterial Exacerbation of Chronic Obstructive Pulmonary Disease.', 'orgStudyIdInfo': {'id': 'DW224-III-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DW224', 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days', 'interventionNames': ['Drug: Zabofloxacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avelox', 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7days', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'Zabofloxacin', 'type': 'DRUG', 'otherNames': ['DW224'], 'description': 'Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days', 'armGroupLabels': ['DW224']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'Moxifloxacin 400mg tablet P.O. once daily for 7days', 'armGroupLabels': ['Avelox']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yeon-Mok Oh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}, {'name': 'Sang-Do Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Wha Pharmaceutical Co. Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Chonbuk National University Hospital', 'class': 'OTHER'}, {'name': 'Chosun University Hospital', 'class': 'OTHER'}, {'name': 'Bundang CHA Hospital', 'class': 'OTHER'}, {'name': 'Chungbuk National University', 'class': 'OTHER'}, {'name': 'Kangdong Sacred Heart Hospital', 'class': 'OTHER'}, {'name': 'Hanyang University', 'class': 'OTHER'}, {'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}, {'name': 'Konyang University Hospital', 'class': 'OTHER'}, {'name': 'KangWon National University Hospital', 'class': 'OTHER'}, {'name': 'Gyeongsang National University Hospital', 'class': 'OTHER'}, {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Korea University Anam Hospital', 'class': 'OTHER'}, {'name': 'DongGuk University', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}, {'name': 'Yeungnam University Hospital', 'class': 'OTHER'}, {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, {'name': 'Ewha Womans University Mokdong Hospital', 'class': 'OTHER'}, {'name': 'Inje University', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': "Catholic University of Korea Saint Paul's Hospital", 'class': 'OTHER'}, {'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}, {'name': 'Masan Samsung Hospital, South Korea', 'class': 'OTHER'}, {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, {'name': 'Keimyung University Dongsan Medical Center', 'class': 'OTHER'}, {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, {'name': 'Ajou University', 'class': 'OTHER'}, {'name': 'Chungnam National University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}