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Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

Primary Purpose

Hyperuricemia With or Without Gout

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
FYU-981
Sponsored by
Mochida Pharmaceutical Company, Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hyperuricemia With or Without Gout

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Serum urate level:

    • >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL
  • Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type
  • Outpatients

Exclusion Criteria:

  • Gouty arthritis within 14 days before randomized allocation

Sites / Locations

  • Mochida Investigational sites

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Uric acid-overproduction Type

Uric acid-underexcretion Type

Arm Description

Outcomes

Primary Outcome Measures

Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)
Pharmacodynamics (Amount of uric acid excreted in urine)

Secondary Outcome Measures

Full Information

First Posted
December 10, 2017
Last Updated
September 21, 2018
Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03375632
Brief Title
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
Official Title
Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
May 29, 2018 (Actual)
Study Completion Date
June 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mochida Pharmaceutical Company, Ltd.
Collaborators
Fuji Yakuhin Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia With or Without Gout

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uric acid-overproduction Type
Arm Type
Experimental
Arm Title
Uric acid-underexcretion Type
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FYU-981
Intervention Description
Oral daily dosing for 14 weeks
Primary Outcome Measure Information:
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
2-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
6-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
10-week
Title
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame
14-week

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Serum urate level: >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type Outpatients Exclusion Criteria: Gouty arthritis within 14 days before randomized allocation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuki Furuno
Organizational Affiliation
Clinical Research Department
Official's Role
Study Director
Facility Information:
Facility Name
Mochida Investigational sites
City
Tokyo
Country
Japan

12. IPD Sharing Statement

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Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

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