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

Mochida Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Hyperuricemia With or Without Gout

Treatments: Drug: FYU-981

Study type: Interventional

Funder types: Industry

Identifiers

NCT03375632

FYU-981-013

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: Male

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Uric acid-overproduction Type

Experimental group

Treatment:

Drug: FYU-981

Uric acid-underexcretion Type

Experimental group

Treatment:

Drug: FYU-981