NCT03100318

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 26, 2018

Status Verified

September 1, 2018

Enrollment Period

1.1 years

First QC Date

March 29, 2017

Last Update Submit

September 24, 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

Benzbromarone

ACTIVE COMPARATOR
Drug: Benzbromarone

Interventions

FYU-981DRUG

Oral daily dosing for 14 weeks

FYU-981
BenzbromaroneDRUG

Oral daily dosing for 14 weeks

Benzbromarone

Eligibility Criteria

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

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 31980978DERIVED

MeSH Terms

Interventions

dotinuradBenzbromarone

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

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

March 29, 2017

First Posted

April 4, 2017

Study Start

April 1, 2017

Primary Completion

April 25, 2018

Study Completion

August 31, 2018

Last Updated

September 26, 2018

Record last verified: 2018-09

Locations

JP(1)