Study of FYU-981 in Hyperuricemia With or Without Gout

NCT ID: NCT02344862

Last Updated: 2015-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

FYU-981 High dose

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

FYU-981 Middle dose

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

FYU-981 Low dose

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo, (Oral daily dosing for 8 weeks)

Intervention Type: DRUG

Subjects randomized to the placebo arm receive placebo.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Placebo, (Oral daily dosing for 8 weeks)

Subjects randomized to the placebo arm receive placebo.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• eGFR: < 60mL/min/1.73m^2
• Systolic blood pressure: >= 180 mmHg
• Diastolic blood pressure: >= 110 mmHg

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fuji Yakuhin Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Japan

Tokyo, , Japan

Countries

Japan

References

Hosoya T, Sano T, Sasaki T, Fushimi M, Ohashi T. Clinical efficacy and safety of dotinurad, a novel selective urate reabsorption inhibitor, in Japanese hyperuricemic patients with or without gout: an exploratory, randomized, multicenter, double-blind, placebo-controlled, parallel-group early phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):44-52. doi: 10.1007/s10157-019-01802-w. Epub 2019 Nov 21.

Reference Type: DERIVED

PMID: 31754882 (View on PubMed)

Other Identifiers

FYU-981-003

Identifier Type: -

Identifier Source: org_study_id