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

Phase 1

Completed

• Conditions: Hyperuricemia With or Without Gout
• Interventions: Drug: FYU-981

• Registration Number: NCT03375632
• Lead Sponsor: Mochida Pharmaceutical Company, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-10
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-18
• Study Start: 2018-01-04
• Primary Completion: 2018-05-29
• Study Completion: 2018-06-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 26

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uric acid-overproduction Type	FYU-981	-
Uric acid-underexcretion Type	FYU-981	-

Primary Outcome Measures

Name	Time	Method
Pharmacodynamics (Amount of uric acid excreted in urine)	14-week

Trial Locations

Locations (1)

Mochida Investigational sites; 🇯🇵 Tokyo, Japan