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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-09

Study Completion Date

2018-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

NCT03375632

Hyperuricemia With or Without Gout

COMPLETED PHASE1

Study of FYU-981 in Hyperuricemia With or Without Gout

NCT02344862

Hyperuricemia

COMPLETED PHASE2

Study of FYU-981 in Hyperuricemia With or Without Gout

NCT03006445

Hyperuricemia With or Without Gout

COMPLETED PHASE3

Study of FYU-981 in Hyperuricemia With or Without Gout

NCT02416167

Hyperuricemia

COMPLETED PHASE2

Efficacy and Safety of Oral Febuxostat in Participants With Gout

NCT00430248

Gout

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperuricemia With or Without Gout

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FYU-981

Group Type EXPERIMENTAL

FYU-981

Intervention Type DRUG

Oral daily dosing for 14 weeks

Febuxostat

Group Type ACTIVE_COMPARATOR

Febuxostat

Intervention Type DRUG

Oral daily dosing for 14 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FYU-981

Oral daily dosing for 14 weeks

Intervention Type DRUG

Febuxostat

Oral daily dosing for 14 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No