CompletedPhase 1

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

Japan26 participantsStarted 2018-01-04

Plain-language 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.

Who can participate

Age range20 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pharmacodynamics (Amount of uric acid excreted in urine)

Timeframe: 2-week

Pharmacodynamics (Amount of uric acid excreted in urine)

Timeframe: 6-week

Pharmacodynamics (Amount of uric acid excreted in urine)

Timeframe: 10-week

Pharmacodynamics (Amount of uric acid excreted in urine)

Timeframe: 14-week

Trial details

NCT IDNCT03375632

SponsorMochida Pharmaceutical Company, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-05-29

View on ClinicalTrials.gov More Hyperuricemia With or Without Gout trials