Study of FYU-981 in Hyperuricemia With or Without Gout
Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is exploratory 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 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 18, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedJanuary 26, 2015
January 1, 2015
6 months
January 18, 2015
January 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percent reduction from baseline in serum urate level at the final visit
8 weeks
Study Arms (4)
FYU-981 High dose
ACTIVE COMPARATORFYU-981 Middle dose
ACTIVE COMPARATORFYU-981 Low dose
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
Subjects randomized to the placebo arm receive placebo.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- eGFR: \< 60mL/min/1.73m\^2
- Systolic blood pressure: \>= 180 mmHg
- Diastolic blood pressure: \>= 110 mmHg
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Japan
Tokyo, Japan
Related Publications (1)
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: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):44-52. doi: 10.1007/s10157-019-01802-w. Epub 2019 Nov 21.
PMID: 31754882DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2015
First Posted
January 26, 2015
Study Start
January 1, 2014
Primary Completion
July 1, 2014
Study Completion
September 1, 2014
Last Updated
January 26, 2015
Record last verified: 2015-01