NCT03372200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
203

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2018

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

5 months

First QC Date

December 10, 2017

Last Update Submit

September 21, 2018

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FYU-981

EXPERIMENTAL
Drug: FYU-981

Febuxostat

ACTIVE COMPARATOR
Drug: Febuxostat

Interventions

FYU-981DRUG

Oral daily dosing for 14 weeks

FYU-981
FebuxostatDRUG

Oral daily dosing for 14 weeks

Febuxostat

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mochida Investigational sites

Tokyo, Japan

Location

MeSH Terms

Interventions

dotinuradFebuxostat

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kazuki Furuno

    Clinical Research Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
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

December 10, 2017

First Posted

December 13, 2017

Study Start

January 9, 2018

Primary Completion

June 4, 2018

Study Completion

July 5, 2018

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

JP(1)