NCT02416167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

April 9, 2015

Last Update Submit

February 13, 2017

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (1)

  • Percent reduction from baseline in serum urate level at the final visit

    12 weeks

Study Arms (5)

FYU-981 High dose

ACTIVE COMPARATOR

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

FYU-981 High middle dose

ACTIVE COMPARATOR

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

FYU-981 Middle dose

ACTIVE COMPARATOR

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

FYU-981 Low dose

ACTIVE COMPARATOR

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

PLACEBO COMPARATOR

Drug: Placebo, (Oral daily dosing for 12 weeks) Subjects randomized to the placebo arm receive placebo.

Drug: Placebo

Interventions

FYU-981DRUG
FYU-981 High doseFYU-981 High middle doseFYU-981 Low doseFYU-981 Middle dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Japan

Tokyo and Other Japanese City, Japan

Location

Related Publications (1)

  • 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: randomized, multicenter, double-blind, placebo-controlled, parallel-group, confirmatory phase 2 study. Clin Exp Nephrol. 2020 Mar;24(Suppl 1):53-61. doi: 10.1007/s10157-019-01818-2. Epub 2019 Dec 3.

    PMID: 31792640DERIVED

MeSH Terms

Conditions

Hyperuricemia

Interventions

dotinurad

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 14, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2016

Study Completion

November 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

JP(1)