NCT02344862

Study of FYU-981 in Hyperuricemia With or Without Gout

Exploratory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIa) Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fuji Yakuhin Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2015-01-26
• Last updated: 2015-01-26

Locations

1 site across 1 country: Japan