Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT03100318
Status:
COMPLETED
Last Update Posted:
2018-09-26
First Post:
2017-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}, {'id': 'D001553', 'term': 'Benzbromarone'}], 'ancestors': [{'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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': 201}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2017-03-29', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction from baseline in serum urate level at the final visit', 'timeFrame': '14 weeks', 'description': 'Percent reduction from baseline in serum urate level at the final visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia With or Without Gout']}, 'referencesModule': {'references': [{'pmid': '31980978', 'type': 'DERIVED', 'citation': 'Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Dotinurad versus benzbromarone in Japanese hyperuricemic patient with or without gout: a randomized, double-blind, parallel-group, phase 3 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):62-70. doi: 10.1007/s10157-020-01849-0. Epub 2020 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hyperuricemic or gout patients\n* Serum urate level:\n\n\\>= 7.0mg/dL in patients with history of gout, or \\>= 8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \\>= 9.0mg/dL\n\nExclusion Criteria:\n\n* Gouty arthritis within two weeks before start of study treatment\n* Secondary hyperuricemia\n* HbA1c: \\>= 8.4%\n* Uric acid-overproduction type in the classification of hyperuricemia\n* History of, clinically significant cardiac, hematologic and hepatic disease\n* Kidney calculi or clinically significant urinary calculi\n* Hepatic dysfuction, or AST: \\>=100 IU/L or ALT: \\>=100 IU/L at the pre-examination\n* eGFR: \\< 30mL/min/1.73m\\^2\n* Systolic blood pressure: \\>= 180 mmHg\n* Diastolic blood pressure: \\>= 110 mmHg'}, 'identificationModule': {'nctId': 'NCT03100318', 'briefTitle': 'Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fuji Yakuhin Co., Ltd.'}, 'officialTitle': 'Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 for Hyperuricemia With or Without Gout to Evaluate the Safety and Noninferiority of FYU-981 (Phase III Study)', 'orgStudyIdInfo': {'id': 'FYU-981-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FYU-981', 'interventionNames': ['Drug: FYU-981']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Benzbromarone', 'interventionNames': ['Drug: Benzbromarone']}], 'interventions': [{'name': 'FYU-981', 'type': 'DRUG', 'description': 'Oral daily dosing for 14 weeks', 'armGroupLabels': ['FYU-981']}, {'name': 'Benzbromarone', 'type': 'DRUG', 'description': 'Oral daily dosing for 14 weeks', 'armGroupLabels': ['Benzbromarone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mochida Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}