Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Primary Purpose
Hyperuricemia With or Without Gout
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Benzbromarone
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia With or Without Gout
Eligibility Criteria
Inclusion Criteria:
- Hyperuricemic or gout patients
- Serum urate level:
>= 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
Exclusion Criteria:
- Gouty arthritis within two weeks before start of study treatment
- Secondary hyperuricemia
- HbA1c: >= 8.4%
- Uric acid-overproduction type in the classification of hyperuricemia
- History of, clinically significant cardiac, hematologic and hepatic disease
- Kidney calculi or clinically significant urinary calculi
- Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination
- eGFR: < 30mL/min/1.73m^2
- Systolic blood pressure: >= 180 mmHg
- Diastolic blood pressure: >= 110 mmHg
Sites / Locations
- Tokyo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
FYU-981
Benzbromarone
Arm Description
Outcomes
Primary Outcome Measures
Percent reduction from baseline in serum urate level at the final visit
Percent reduction from baseline in serum urate level at the final visit
Secondary Outcome Measures
Full Information
NCT ID
NCT03100318
First Posted
March 29, 2017
Last Updated
September 24, 2018
Sponsor
Fuji Yakuhin Co., Ltd.
Collaborators
Mochida Pharmaceutical Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03100318
Brief Title
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
April 25, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuji Yakuhin Co., Ltd.
Collaborators
Mochida Pharmaceutical Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia With or Without Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FYU-981
Arm Type
Experimental
Arm Title
Benzbromarone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Description
Oral daily dosing for 14 weeks
Intervention Type
Drug
Intervention Name(s)
Benzbromarone
Intervention Description
Oral daily dosing for 14 weeks
Primary Outcome Measure Information:
Title
Percent reduction from baseline in serum urate level at the final visit
Description
Percent reduction from baseline in serum urate level at the final visit
Time Frame
14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hyperuricemic or gout patients
Serum urate level:
>= 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
Exclusion Criteria:
Gouty arthritis within two weeks before start of study treatment
Secondary hyperuricemia
HbA1c: >= 8.4%
Uric acid-overproduction type in the classification of hyperuricemia
History of, clinically significant cardiac, hematologic and hepatic disease
Kidney calculi or clinically significant urinary calculi
Hepatic dysfuction, or AST: >=100 IU/L or ALT: >=100 IU/L at the pre-examination
eGFR: < 30mL/min/1.73m^2
Systolic blood pressure: >= 180 mmHg
Diastolic blood pressure: >= 110 mmHg
Facility Information:
Facility Name
Tokyo
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
31980978
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.
Results Reference
derived
Learn more about this trial
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
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