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Study of FYU-981 in Hyperuricemia With or Without Gout

NCT02344862 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2015-01-26

No results posted yet for this study

Summary

The purpose of this study is exploratory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered orally to hyperuricemic patients with and without gout for 8 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 4 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

Conditions

  • Hyperuricemia

Interventions

DRUG

FYU-981 High dose, (Oral daily dosing for 8 weeks)

Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.

DRUG

FYU-981 Middle dose, (Oral daily dosing for 8 weeks)

Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.

DRUG

FYU-981 Low dose, (Oral daily dosing for 8 weeks)

Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.

DRUG

Placebo, (Oral daily dosing for 8 weeks)

Subjects randomized to the placebo arm receive placebo.

Sponsors & Collaborators

  • Fuji Yakuhin Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02344862 on ClinicalTrials.gov