Study of FYU-981 in Hyperuricemia With or Without Gout

Sponsor

Fuji Yakuhin Co., Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT02416167

Collaborator

(none)

200

Enrollment

Location

Arms

18.1

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is confirmatory 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 12 weeks (dose-escalating initial period: 4 weeks followed by maintenance period: 8 weeks) by the method of randomized (dynamic allocation), placebo-controlled, double-blind, parallel group comparison.

Condition or Disease	Intervention/Treatment	Phase
Hyperuricemia	Drug: FYU-981 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Confirmatory Study of FYU-981 for Hyperuricemia With or Without Gout (Phase II (IIb) Study)

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FYU-981 High dose Drug: FYU-981 High dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.	Drug: FYU-981
Active Comparator: FYU-981 High middle dose Drug: FYU-981 High middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 High middle dose arm receive active drug, FYU-981 High middle dose.	Drug: FYU-981
Active Comparator: FYU-981 Middle dose FYU-981 Middle dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.	Drug: FYU-981
Active Comparator: FYU-981 Low dose Drug: FYU-981 Low dose, (Oral daily dosing for 8 week-maintenance period) Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.	Drug: FYU-981
Placebo Comparator: Placebo Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Percent reduction from baseline in serum urate level at the final visit [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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: < 30mL/min/1.73m^2
Systolic blood pressure: >= 180 mmHg
Diastolic blood pressure: >= 110 mmHg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Japan	Tokyo and Other Japanese City		Japan

Sponsors and Collaborators

Fuji Yakuhin Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fuji Yakuhin Co., Ltd.

ClinicalTrials.gov Identifier:

NCT02416167

Other Study ID Numbers:

FYU-981-006

First Posted:

Apr 14, 2015

Last Update Posted:

Feb 14, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Hyperuricemia

Dotinurad

Study Results

No Results Posted as of Feb 14, 2017