Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-24 @ 11:11 AM
Study NCT ID:
NCT01768520
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2013-01-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee
Sponsor:
Organization:
Raw JSON
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(celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 22, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 16, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nocturia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nasolacrimal duct obstruction,Right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Epigastric pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Esophageal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Middle cerebral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'three abscess cavities scattered in both hepatic lobes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Entelon Tab. 150mg', 'description': 'Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg'}, {'id': 'OG001', 'title': 'Celebrex Cap.', 'description': 'Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '51.64', 'spread': '13.62', 'groupId': 'OG000'}, {'value': '54.57', 'spread': '14.06', 'groupId': 'OG001'}, {'value': '49.94', 'spread': '11.81', 'groupId': 'OG002'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '30.68', 'spread': '18.69', 'groupId': 'OG000'}, {'value': '33.88', 'spread': '20.44', 'groupId': 'OG001'}, {'value': '33.80', 'spread': '15.98', 'groupId': 'OG002'}]}]}, {'title': 'change(12 weeks-baseline)', 'categories': [{'measurements': [{'value': '-19.38', 'spread': '19.79', 'groupId': 'OG000'}, {'value': '-19.26', 'spread': '18.22', 'groupId': 'OG001'}, {'value': '-16.70', 'spread': '20.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome.\n\nRange of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0\\~68) Higher scores mean a worse outcome.\n\nIf there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'the Change of Numeric Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Entelon Tab. 150mg', 'description': 'Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg'}, {'id': 'OG001', 'title': 'Celebrex Cap.', 'description': 'Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '5.62', 'spread': '1.40', 'groupId': 'OG000'}, {'value': '5.54', 'spread': '1.73', 'groupId': 'OG001'}, {'value': '5.44', 'spread': '1.67', 'groupId': 'OG002'}]}]}, {'title': '12 weeks', 'categories': [{'measurements': [{'value': '3.57', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '4.09', 'spread': '2.09', 'groupId': 'OG001'}, {'value': '4.23', 'spread': '2.22', 'groupId': 'OG002'}]}]}, {'title': 'change(12weeks-baseline)', 'categories': [{'measurements': [{'value': '-2.14', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '2.34', 'groupId': 'OG001'}, {'value': '-1.50', 'spread': '1.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'Numeric Rating Scale is 10 point scale(0\\~10 score). 0 score: no pain, 10 score: worst possible pain\n\nIf there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Entelon Tab. 150mg', 'description': 'Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg'}, {'id': 'FG001', 'title': 'Celebrex Cap.', 'description': 'Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Entelon Tab. 150mg', 'description': 'Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks: 1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex 2. evening : 1 tab. of active Entelon 150mg'}, {'id': 'BG001', 'title': 'Celebrex Cap.', 'description': 'Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo: 1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex 2. evening : 1 tab. of placebo Entelon 150mg'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '61.41', 'spread': '7.41', 'groupId': 'BG000'}, {'value': '62.24', 'spread': '7.12', 'groupId': 'BG001'}, {'value': '64.13', 'spread': '6.76', 'groupId': 'BG002'}, {'value': '62.09', 'spread': '7.24', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '260', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Part of Osteoarthritis diagnosis', 'classes': [{'title': 'Right knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}]}]}, {'title': 'Left knee', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '338', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '179', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 338}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2015-05-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-23', 'studyFirstSubmitDate': '2013-01-14', 'resultsFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2013-01-14', 'lastUpdatePostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-28', 'studyFirstPostDateStruct': {'date': '2013-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the Change of Total Sum of K-WOMAC(Korean The Western Ontario and McMaster Universities Arthritis Index)', 'timeFrame': 'baseline and 12 weeks', 'description': 'Range of total K-WOMAC score: 0-96 K-WOMAC consists of evaluations of pain, stiffness, physical function. The total K-WOMAC score is the sum of all subscale scores. Higher scores mean a worse outcome.\n\nRange of Subscale K-WOMAC score: pain(0-20), stiffness(0-8), physical function(0\\~68) Higher scores mean a worse outcome.\n\nIf there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.'}], 'secondaryOutcomes': [{'measure': 'the Change of Numeric Rating Scale', 'timeFrame': 'baseline and 12 weeks', 'description': 'Numeric Rating Scale is 10 point scale(0\\~10 score). 0 score: no pain, 10 score: worst possible pain\n\nIf there is missing data, LOCF(Last Observation Carried Forward) was applied and analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': "This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. both gender,35 years ≤ age ≤ 75 years\n2. patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the American College of Rheumatology clinical and radiographic criteria as follows.\n\n 1. knee arthralgia\n 2. more than one case among\n\n * 50 years or over\n\n * morning stiffness less than 30 min\n\n * friction sound\n 3. osteophyte in radiography\n3. Kellgren and Lawrence Scale Grade II\\~III\n4. total sum of K-WOMAC Scale more than 30\n5. negative results in pregnancy test of urine in screening period\n6. if women in childbearing age, medically reliable contraception or menopause\n7. patients who give written consent of agreement to voluntarily participate in the clinical study\n8. patients who can read and understand written instructions\n\nExclusion Criteria:\n\n1. patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1\n2. fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout\n3. knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis\n4. anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint\n5. wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation\n6. patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation\n7. severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma\n8. medical history of malignant tumor\n9. active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease\n10. hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose\n11. continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation\n12. pregnant or lactating women\n13. patients who have experience to participate in other clinical trial within 4 weeks prior to study participation\n14. ALT, AST and Serum Creatinine ≥ 2×UNL\n15. drug administration after diagnosing as alcoholic or psychical disease\n16. patients whom the investigators judge as improper to participate in this clinical trial"}, 'identificationModule': {'nctId': 'NCT01768520', 'briefTitle': 'Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanlim Pharm. Co., Ltd.'}, 'officialTitle': 'For 12 Weeks, the Multi-center, Randomized, Double-blinded, Clinical Study to Evaluate the Efficacy and Safety of Entelon Tab. 150mg Compared With Celebrex Capsule in Patients With Osteoarthritis of Knee (Phase III)', 'orgStudyIdInfo': {'id': 'HL_ENTR_302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Entelon tab. 150mg', 'interventionNames': ['Drug: Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celebrex cap.', 'interventionNames': ['Drug: Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks', 'type': 'DRUG', 'description': '1. morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex\n2. evening : 1 tab. of active Entelon 150mg', 'armGroupLabels': ['Entelon tab. 150mg']}, {'name': 'Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks', 'type': 'DRUG', 'description': '1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex\n2. evening : 1 tab. of placebo Entelon 150mg', 'armGroupLabels': ['Celebrex cap.']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1. morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex\n2. evening : 1 tab. of placebo Entelon 150mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '420-717', 'city': 'Bucheon-si', 'state': 'Kyoung-gi Do', 'country': 'South Korea', 'facility': "The Catholic University of Korea, Bucheon St. Mary's Hospital", 'geoPoint': {'lat': 37.49889, 'lon': 126.78306}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}