Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2026-02-23 @ 12:20 PM
Study NCT ID:
NCT02416167
Status:
COMPLETED
Last Update Posted:
2017-02-14
First Post:
2015-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FYU-981 in Hyperuricemia With or Without Gout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D033461', 'term': 'Hyperuricemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-13', 'studyFirstSubmitDate': '2015-04-09', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent reduction from baseline in serum urate level at the final visit', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperuricemia']}, 'referencesModule': {'references': [{'pmid': '31792640', 'type': 'DERIVED', 'citation': 'Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):53-61. doi: 10.1007/s10157-019-01818-2. Epub 2019 Dec 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.'}, '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* eGFR: \\< 30mL/min/1.73m\\^2\n* Systolic blood pressure: \\>= 180 mmHg\n* Diastolic blood pressure: \\>= 110 mmHg'}, 'identificationModule': {'nctId': 'NCT02416167', 'briefTitle': 'Study of FYU-981 in Hyperuricemia With or Without Gout', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fuji Yakuhin Co., Ltd.'}, 'officialTitle': 'Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)', 'orgStudyIdInfo': {'id': 'FYU-981-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FYU-981 High dose', 'description': 'Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.', 'interventionNames': ['Drug: FYU-981']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FYU-981 High middle dose', 'description': 'Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.', 'interventionNames': ['Drug: FYU-981']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FYU-981 Middle dose', 'description': 'FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.', 'interventionNames': ['Drug: FYU-981']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FYU-981 Low dose', 'description': 'Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.', 'interventionNames': ['Drug: FYU-981']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'FYU-981', 'type': 'DRUG', 'armGroupLabels': ['FYU-981 High dose', 'FYU-981 High middle dose', 'FYU-981 Low dose', 'FYU-981 Middle dose']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo and Other Japanese City', 'country': 'Japan', 'facility': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}