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

September 21, 2018 updated by: Mochida Pharmaceutical Company, Ltd.

Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Mochida Investigational sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Uric acid-overproduction Type
Drug: FYU-981
Oral daily dosing for 14 weeks
EXPERIMENTAL: Uric acid-underexcretion Type
Drug: FYU-981
Oral daily dosing for 14 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame: 2-week
2-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame: 6-week
6-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame: 10-week
10-week
Pharmacodynamics (Amount of uric acid excreted in urine)
Time Frame: 14-week
14-week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mochida Pharmaceutical Company, Ltd.

Collaborators

Fuji Yakuhin Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 4, 2018

Primary Completion (ACTUAL)

May 29, 2018

Study Completion (ACTUAL)

June 5, 2018

Study Registration Dates

First Submitted

December 10, 2017

First Submitted That Met QC Criteria

December 14, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FYU-981-013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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