Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2026-02-19 @ 9:28 PM
Study NCT ID:
NCT03375632
Status:
COMPLETED
Last Update Posted:
2018-09-24
First Post:
2017-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2017-12-10', 'studyFirstSubmitQcDate': '2017-12-14', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacodynamics (Amount of uric acid excreted in urine)', 'timeFrame': '2-week'}, {'measure': 'Pharmacodynamics (Amount of uric acid excreted in urine)', 'timeFrame': '6-week'}, {'measure': 'Pharmacodynamics (Amount of uric acid excreted in urine)', 'timeFrame': '10-week'}, {'measure': 'Pharmacodynamics (Amount of uric acid excreted in urine)', 'timeFrame': '14-week'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperuricemia With or Without Gout']}, 'descriptionModule': {'briefSummary': 'To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serum urate level:\n\n * \\>= 7.0mg/dL in patients with gouty nodule or with history of gout, or \\>=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or \\>= 9.0mg/dL\n* Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type\n* Outpatients\n\nExclusion Criteria:\n\n* Gouty arthritis within 14 days before randomized allocation'}, 'identificationModule': {'nctId': 'NCT03375632', 'briefTitle': 'Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mochida Pharmaceutical Company, Ltd.'}, 'officialTitle': 'Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout', 'orgStudyIdInfo': {'id': 'FYU-981-013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uric acid-overproduction Type', 'interventionNames': ['Drug: FYU-981']}, {'type': 'EXPERIMENTAL', 'label': 'Uric acid-underexcretion Type', 'interventionNames': ['Drug: FYU-981']}], 'interventions': [{'name': 'FYU-981', 'type': 'DRUG', 'description': 'Oral daily dosing for 14 weeks', 'armGroupLabels': ['Uric acid-overproduction Type', 'Uric acid-underexcretion Type']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Mochida Investigational sites', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Kazuki Furuno', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mochida Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}