Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-04 @ 3:15 PM
Study NCT ID:
NCT02082769
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Oral Febuxostat in Subjects With Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069465', 'term': 'Febuxostat'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'qiuheji@hotmail.com', 'phone': '+86-29-84775213', 'title': 'Qiuhe Ji', 'organization': 'Department of Endocrinology, Xijing Hospital, Fourth Military Medical University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat', 'otherNumAtRisk': 168, 'otherNumAffected': 45, 'seriousNumAtRisk': 168, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat', 'otherNumAtRisk': 168, 'otherNumAffected': 46, 'seriousNumAtRisk': 168, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol', 'otherNumAtRisk': 168, 'otherNumAffected': 41, 'seriousNumAtRisk': 168, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Liver function test abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal function test abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal electrocardiogram', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal urine protein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Drug allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Others', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hydronephrosis', 'notes': 'The subject was diagnosed as hydronephrosis after 14-day period of febuxostat administration and thus hospitalized.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '33.5', 'groupId': 'OG001'}, {'value': '17.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Last 3 visits (any last 3 visits up to week 26)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000'}, {'value': '58.9', 'groupId': 'OG001'}, {'value': '34.6', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Final Visit (up to 26 weeks)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '159', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'OG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol'}], 'classes': [{'categories': [{'measurements': [{'value': '182.2', 'spread': '115.6', 'groupId': 'OG000'}, {'value': '216.0', 'spread': '137.2', 'groupId': 'OG001'}, {'value': '170.4', 'spread': '132.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Final Visit (up to 26 weeks)', 'unitOfMeasure': 'umol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'FG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'FG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '168'}, {'groupId': 'FG001', 'numSubjects': '168'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '141'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '36'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '477', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'BG001', 'title': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks\n\nFebuxostat'}, {'id': 'BG002', 'title': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks\n\nAllopurinol'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '159', 'groupId': 'BG002'}, {'value': '477', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'spread': '11.9', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '46.5', 'spread': '10.7', 'groupId': 'BG002'}, {'value': '46.7', 'spread': '11.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '453', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '25.1', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '25.4', 'spread': '3.3', 'groupId': 'BG002'}, {'value': '25.2', 'spread': '2.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure (SBP)', 'classes': [{'categories': [{'measurements': [{'value': '126.2', 'spread': '10.0', 'groupId': 'BG000'}, {'value': '126.4', 'spread': '11.0', 'groupId': 'BG001'}, {'value': '124.8', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '126.4', 'spread': '10.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure (DBP)', 'classes': [{'categories': [{'measurements': [{'value': '79.1', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '77.6', 'spread': '8.1', 'groupId': 'BG001'}, {'value': '78.7', 'spread': '7.9', 'groupId': 'BG002'}, {'value': '78.5', 'spread': '8.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Baseline serum urate level units', 'classes': [{'categories': [{'measurements': [{'value': '560.8', 'spread': '73.3', 'groupId': 'BG000'}, {'value': '565.1', 'spread': '75.5', 'groupId': 'BG001'}, {'value': '574.2', 'spread': '77.8', 'groupId': 'BG002'}, {'value': '566.7', 'spread': '75.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'umol/l', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'full analysis set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 504}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-30', 'studyFirstSubmitDate': '2014-03-06', 'resultsFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-30', 'studyFirstPostDateStruct': {'date': '2014-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Absolute Change in the Serum Urate Level at the Final Visit Relative to Baseline', 'timeFrame': 'Baseline and Final Visit (up to 26 weeks)'}], 'primaryOutcomes': [{'measure': 'Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL)', 'timeFrame': 'Last 3 visits (any last 3 visits up to week 26)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit', 'timeFrame': 'Final Visit (up to 26 weeks)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gout', 'Uric Acid', 'Xanthine oxidase', 'Febuxostat'], 'conditions': ['Gout']}, 'referencesModule': {'references': [{'pmid': '26013187', 'type': 'DERIVED', 'citation': 'Xu S, Liu X, Ming J, Chen S, Wang Y, Liu X, Liu H, Peng Y, Wang J, Lin J, Ji H, Liu B, Lu Y, Liu P, Zhang Y, Ji Q. A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia. Int J Rheum Dis. 2015 Jul;18(6):669-78. doi: 10.1111/1756-185X.12648. Epub 2015 May 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare febuxostat allopurinol in subjects with gout.', 'detailedDescription': 'A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;\n* Renal function defined as a serum creatinine level of \\< 2.0 mg/dL and creatinine clearance of \\> 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;\n* No gout flare 2 weeks beforehand during 2-week screening period.\n\nExclusion Criteria:\n\n* Pregnancy or lactation;\n* Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\\>325 mg) or other salicylates;\n* Body Mass Index (BMI) \\>50 kilogram per meter²(kg/m²);\n* A history of active liver disease, or hepatic dysfunction;\n* A history of bronchial asthma;\n* A history of renal calculi or thyroid disease;\n* Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;\n* Intolerance to allopurinol and Ibuprofen;\n* Alcohol intake of ≥ 14 drinks/week;\n* Clinically significant medical condition.'}, 'identificationModule': {'nctId': 'NCT02082769', 'briefTitle': 'Safety and Efficacy of Oral Febuxostat in Subjects With Gout', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout', 'orgStudyIdInfo': {'id': 'SFDA2010L04287'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Febuxostat 40 mg QD', 'description': 'Febuxostat 40 mg, orally, once daily for up to 24 weeks', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'EXPERIMENTAL', 'label': 'Febuxostat 80 mg QD', 'description': 'Febuxostat 80 mg, orally, once daily for up to 24 weeks', 'interventionNames': ['Drug: Febuxostat']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allopurinol 100mg QD', 'description': 'Allopurinol 100mg, orally, three times daily for up to 24 weeks', 'interventionNames': ['Drug: Allopurinol']}], 'interventions': [{'name': 'Febuxostat', 'type': 'DRUG', 'armGroupLabels': ['Febuxostat 40 mg QD', 'Febuxostat 80 mg QD']}, {'name': 'Allopurinol', 'type': 'DRUG', 'armGroupLabels': ['Allopurinol 100mg QD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Shenren Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Shantou University Medical College'}, {'name': 'Yangang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Hospital of Qingdao University'}, {'name': 'Xiumei Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Shanxi Medical University'}, {'name': 'Hong Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Guangxi Medical University'}, {'name': 'Yongde Peng, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, {'name': 'Jianqin Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lanzhou University Second Hospital'}, {'name': 'Jinying Lin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Guangxi Zhuang Autonomous Region"}, {'name': 'Haiwang Ji, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shaanxi Provincial People's Hospital"}, {'name': 'Bin Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Ying Lu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zhejiang Provincial Tongde Hospital'}, {'name': 'Peng Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangxi Ruikang Hospital'}, {'name': 'Yonghong Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luoyang Orthopedic-Traumatological Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qingdao Shengbang Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}