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Febuxostat-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
Febuxostat
Sponsored by
Mochida Pharmaceutical Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperuricemia With or Without Gout

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mochida Investigational sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FYU-981

Febuxostat

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

First Posted
December 10, 2017
Last Updated
September 21, 2018
Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03372200
Brief Title
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
June 4, 2018 (Actual)
Study Completion Date
July 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

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
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FYU-981
Arm Type
Experimental
Arm Title
Febuxostat
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)
Febuxostat
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuki Furuno
Organizational Affiliation
Clinical Research Department
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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