Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout

Febuxostat-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)

FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) 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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia With or Without Gout
• Intervention / Treatment: Drug: FYU-981; Drug: Febuxostat

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Mochida Investigational sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Serum urate level:

  • >= 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
• Disease type in the classification of hyperuricemia: Uric acid-underexcretion type or mixed type
• Outpatients

Exclusion Criteria:

• Gouty arthritis within 14 days before randomized allocation
• Secondary hyperuricemia
• HbA1c: >= 8.4%
• Clinically significant cardiac, hepatic, renal, hematologic or endocrine disease
• Kidney calculi or clinically significant urinary calculi
• AST: >= 100 IU/L or ALT: >= 100 IU/L
• eGFR: < 30 mL/min/1.73m^2
• Systolic blood pressure: >= 180 mmHg or diastolic blood pressure: >= 110 mmHg

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Febuxostat	Drug: Febuxostat; Oral daily dosing for 14 weeks
Experimental: FYU-981	Drug: FYU-981; Oral daily dosing for 14 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent reduction from baseline in serum urate level at the final visit	Percent reduction from baseline in serum urate level at the final visit	14 weeks

Collaborators and Investigators

• Sponsor: Mochida Pharmaceutical Company, Ltd.
• Collaborators: Fuji Yakuhin Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2018
• Primary Completion (Actual): June 4, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: December 12, 2017
• First Posted (Actual): December 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2018
• Last Update Submitted That Met QC Criteria: September 21, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Antirheumatic Agents; Gout Suppressants; Renal Agents; Uricosuric Agents; Febuxostat; Dotinurad
• Other Study ID Numbers: FYU-981-014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No