Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT01510769
Status:
COMPLETED
Last Update Posted:
2016-05-26
First Post:
2012-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Spain']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593471', 'term': 'lesinurad'}, {'id': 'D000069465', 'term': 'Febuxostat'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfung@ardeabio.com', 'phone': '1-858-652-6671', 'title': 'Maple Fung, MD', 'organization': 'Ardea Biosciences, Inc.'}, 'certainAgreement': {'otherDetails': "PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Lesinurad 200 mg + Febuxostat', 'otherNumAtRisk': 106, 'otherNumAffected': 50, 'seriousNumAtRisk': 106, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Lesinurad 400 mg + Febuxostat', 'otherNumAtRisk': 109, 'otherNumAffected': 59, 'seriousNumAtRisk': 109, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Placebo + Febuxostat', 'otherNumAtRisk': 109, 'otherNumAffected': 34, 'seriousNumAtRisk': 109, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': 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'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 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{'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Joint contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 106, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 109, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0.02'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Febuxostat 80 mg', 'description': 'lesinurad 200 mg once daily (qd) plus febuxostat 80 mg'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Febuxostat 80 mg', 'description': 'lesinurad 400 mg qd plus febuxostat 80 mg'}, {'id': 'OG002', 'title': 'Placebo + Febuxostat 80 mg', 'description': 'placebo qd plus febuxostat 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.566', 'groupId': 'OG000'}, {'value': '0.761', 'groupId': 'OG001'}, {'value': '0.468', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.1298', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.23', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.17', 'ciUpperLimit': '0.42', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '6 months, analysis after all subjects complete 12 months', 'description': 'Proportion of subjects with an sUA level that is \\< 5.0 mg/dL by Month 6', 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Complete Resolution of at Least One Target Tophus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Febuxostat 80 mg', 'description': 'lesinurad 200 mg once daily (qd) plus febuxostat 80 mg'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Febuxostat 80 mg', 'description': 'lesinurad 400 mg qd plus febuxostat 80 mg'}, {'id': 'OG002', 'title': 'Placebo + Febuxostat 80 mg', 'description': 'placebo qd plus febuxostat 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.255', 'groupId': 'OG000'}, {'value': '0.303', 'groupId': 'OG001'}, {'value': '0.211', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4453', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.07', 'ciUpperLimit': '0.16', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1149', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.21', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12', 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Complete or Partial Response of at Least One Tophus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Febuxostat 80 mg', 'description': 'lesinurad 200 mg once daily (qd) plus febuxostat 80 mg'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Febuxostat 80 mg', 'description': 'lesinurad 400 mg qd plus febuxostat 80 mg'}, {'id': 'OG002', 'title': 'Placebo + Febuxostat 80 mg', 'description': 'placebo qd plus febuxostat 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.566', 'groupId': 'OG000'}, {'value': '0.587', 'groupId': 'OG001'}, {'value': '0.505', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6450', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.10', 'ciUpperLimit': '0.17', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4118', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.08', 'ciUpperLimit': '0.19', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12', 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Lesinurad 200 mg + Febuxostat 80 mg', 'description': 'lesinurad 200 mg once daily (qd) plus febuxostat 80 mg'}, {'id': 'OG001', 'title': 'Lesinurad 400 mg + Febuxostat 80 mg', 'description': 'lesinurad 400 mg qd plus febuxostat 80 mg'}, {'id': 'OG002', 'title': 'Placebo + Febuxostat 80 mg', 'description': 'placebo qd plus febuxostat 80 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.442', 'groupId': 'OG000'}, {'value': '0.333', 'groupId': 'OG001'}, {'value': '0.525', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3034', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '0.07', 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The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability.", 'unitOfMeasure': 'Proportion of Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lesinurad 200 mg + Febuxostat'}, {'id': 'FG001', 'title': 'Lesinurad 400 mg + Febuxostat'}, {'id': 'FG002', 'title': 'Placebo + Febuxostat'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '106'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '109'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}, {'groupId': 'FG001', 'numSubjects': '84'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Gout Flare', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '330 participants were randomized and 324 participants were included in the Intent-to-Treat (ITT) population (ie, 6 subjects were randomized but not treated).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lesinurad 200 mg + Febuxostat'}, {'id': 'BG001', 'title': 'Lesinurad 400 mg + Febuxostat'}, {'id': 'BG002', 'title': 'Placebo + Febuxostat'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.2', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '54.6', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '54.1', 'spread': '11.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65 Years', 'categories': [{'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}]}, {'title': '>=65 Years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': '\\<65 Years, \\>=65 Years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}, {'value': '309', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '244', 'groupId': 'BG003'}]}]}], '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': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2015-03-23', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2012-01-12', 'dispFirstSubmitQcDate': '2015-03-23', 'resultsFirstSubmitDate': '2016-01-14', 'studyFirstSubmitQcDate': '2012-01-13', 'dispFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-20', 'studyFirstPostDateStruct': {'date': '2012-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6', 'timeFrame': '6 months, analysis after all subjects complete 12 months', 'description': 'Proportion of subjects with an sUA level that is \\< 5.0 mg/dL by Month 6'}], 'secondaryOutcomes': [{'measure': 'Complete Resolution of at Least One Target Tophus', 'timeFrame': '12 Months', 'description': 'Proportion of subjects who experience complete resolution of at least 1 target tophus by Month 12'}, {'measure': 'Complete or Partial Response of at Least One Tophus', 'timeFrame': '12 Months', 'description': 'Proportion of subjects with a best tophus response on at least 1 target tophus of complete (disappearance of at least 1 target tophus) or partial (≥ 50% decrease in the area of at least 1 target tophus) resolution by Month 12'}, {'measure': 'Quality of Life', 'timeFrame': '12 Months', 'description': "Proportion of subjects with an improvement from Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at least 0.25 at Month 12. The HAQ-DI assesses a patient's level of functional ability with items scores ranging from 0-3 with 0 being the least disability."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tophaceous Gout']}, 'referencesModule': {'references': [{'pmid': '35835008', 'type': 'DERIVED', 'citation': 'Topless R, Noorbaloochi S, Merriman TR, Singh JA. Change in serum urate level with urate-lowering therapy initiation associates in the immediate term with patient-reported outcomes in people with gout. Semin Arthritis Rheum. 2022 Oct;56:152057. doi: 10.1016/j.semarthrit.2022.152057. Epub 2022 Jun 29.'}, {'pmid': '30616614', 'type': 'DERIVED', 'citation': 'Dalbeth N, Jones G, Terkeltaub R, Khanna D, Fung M, Baumgartner S, Perez-Ruiz F. Efficacy and safety during extended treatment of lesinurad in combination with febuxostat in patients with tophaceous gout: CRYSTAL extension study. Arthritis Res Ther. 2019 Jan 7;21(1):8. doi: 10.1186/s13075-018-1788-4.'}, {'pmid': '28597604', 'type': 'DERIVED', 'citation': 'Dalbeth N, Jones G, Terkeltaub R, Khanna D, Kopicko J, Bhakta N, Adler S, Fung M, Storgard C, Baumgartner S, Perez-Ruiz F. Lesinurad, a Selective Uric Acid Reabsorption Inhibitor, in Combination With Febuxostat in Patients With Tophaceous Gout: Findings of a Phase III Clinical Trial. Arthritis Rheumatol. 2017 Sep;69(9):1903-1913. doi: 10.1002/art.40159. Epub 2017 Aug 4.'}], 'seeAlsoLinks': [{'url': 'http://www.gouttrial.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout.', 'detailedDescription': 'Febuxostat is an XO (Xanthine Oxidase) Inhibitor approved Urate Lowering Therapy (ULT) for patients with gout. Although febuxostat has been demonstrated to be superior to allopurinol in lowering serum urate (sUA) to \\< 6mg/dL in 3 randomized, controlled clinical trials, proportions of subjects experiencing a reduction in tophus area and gout flares were not significantly different compared to allopurinol. Although this study will allow subjects who are naïve to ULT to enroll, it is anticipated that the majority of subjects will currently be taking or have previously experienced XO Inhibitor therapy. This trial will enroll a population of subjects with high uric acid body burden, as all must demonstrate the presence of tophi.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.\n* Subject is willing to adhere to the visit/protocol schedules.\n* Subject meets the diagnosis of gout as per the American Rheumatism Association\n* Criteria for the Classification of Acute Arthritis of Primary Gout.\n* Subject meets one of the following criteria:\n* Subjects who are not currently taking an approved ULT must have an sUA value of ≥ 8 mg/dL (476 µmol/L).\n* Subjects entering the study on a medically appropriate dose of febuxostat or allopurinol must have an sUA value of ≥ 6.0 mg/dL (357 µmol/L).\n* Subject must be able to take gout flare prophylaxis with colchicine or non-steroidal anti-inflammatory drug (NSAID) (including Cox-2 selective NSAID) ± PPI.\n* Subject with at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 20 mm in the longest diameter.\n* Body mass index (BMI) \\< 45 kg/m2\n\nExclusion Criteria:\n\n* Subject with known hypersensitivity or allergy to febuxostat.\n* Subject who is taking any approved urate-lowering medication other than allopurinol or febuxostat that is indicated for the treatment of gout within 8 weeks of the Screening Visit.\n* Subject who previously received pegloticase.\n* Subject who consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \\[150 mL\\] of wine, 12 oz \\[360 mL\\] of beer, or 1.5 oz \\[45 mL\\] of hard liquor).\n* Subject with a history or suspicion of drug abuse within the past 5 years.\n* Subject with a history of myositis/myopathy or rhabdomyolysis.\n* Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.\n* Subject with known or suspected human immunodeficiency virus (HIV) infection.\n* Subject with a positive test for active hepatitis B or hepatitis C infection.\n* Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.\n* Subject within the last 12 months with: unstable angina, New York Heart Association thrombosis; or subjects currently receiving anticoagulants.\n* Subject with uncontrolled hypertension.\n* Subject with an estimated creatinine clearance \\< 30 mL/min.\n* Subjects with a creatine kinase \\> 2.5 x ULN at any time during the Screening Period.\n* Subject with active peptic ulcer disease requiring treatment.\n* Subject with a history of xanthinuria, active liver disease, or hepatic dysfunction.\n* Subject receiving chronic treatment with more than 325 mg of salicylates per day.\n* Subject taking valpromide, progabide, or valproic acid.\n* Subject who has received an investigational therapy within 8 weeks or 5 half-lives (whichever is longer) prior to the Screening Visit.\n* Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study."}, 'identificationModule': {'nctId': 'NCT01510769', 'acronym': 'CRYSTAL', 'briefTitle': 'Combination Treatment Study in Subjects With Tophaceous Gout With Lesinurad and Febuxostat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardea Biosciences, Inc.'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Multicenter, Placebo- Controlled, Combination Study to Evaluate the Efficacy and Safety of Lesinurad and Febuxostat Compared to Febuxostat Alone at Lowering Serum Uric Acid and Resolving Tophi in Subjects With Tophaceous Gout', 'orgStudyIdInfo': {'id': 'RDEA594-304'}, 'secondaryIdInfos': [{'id': '2011-003768-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lesinurad 400 mg + febuxostat 80 mg', 'interventionNames': ['Drug: Lesinurad', 'Drug: Febuxostat']}, {'type': 'EXPERIMENTAL', 'label': 'lesinurad 200 mg + febuxostat 80 mg', 'interventionNames': ['Drug: Lesinurad', 'Drug: Febuxostat']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo + febuxostat 80 mg', 'interventionNames': ['Drug: Placebo', 'Drug: Febuxostat']}], 'interventions': [{'name': 'Lesinurad', 'type': 'DRUG', 'description': 'Tablets, 400 mg once daily (QD)', 'armGroupLabels': ['lesinurad 400 mg + febuxostat 80 mg']}, {'name': 'Lesinurad', 'type': 'DRUG', 'description': 'Tablets, 200 mg QD', 'armGroupLabels': ['lesinurad 200 mg + febuxostat 80 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, Placebo QD', 'armGroupLabels': ['placebo + febuxostat 80 mg']}, {'name': 'Febuxostat', 'type': 'DRUG', 'description': '80 mg', 'armGroupLabels': ['lesinurad 200 mg + febuxostat 80 mg', 'lesinurad 400 mg + febuxostat 80 mg', 'placebo + febuxostat 80 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85023', 'city': 'Pheonix', 'state': 'Arizona', 'country': 'United States'}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72204', 'city': 'Little Rock', 'state': 'Arkansas', 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