A Phase III Study of FYU-981 in Hyperuricemic Pediatric Patients with or without Gout (Extension Study)

JRCT ID: jRCT2041220061

Registered date:31/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hyperuricemic pediatric patients with or without gout
• Date of first enrollment: 12/01/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): FYU-981 is administered orally once daily with the maintenance doses of 0.5 to 4 mg/day.

Outcome(s)

• Primary Outcome: Percentage of subjects with serum urate <=6.0 mg/dL at the end of administration

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: -Hyperuricemic pediatric patients with or without gout, who completed the observation for 30 weeks of Study FYU-981-018 (jRCT2031220036).

Exclude criteria

-Kidney calculi or clinically significant urinary calculi
-Patients deemed inappropriate by the investigator to conduct this study
etc.

Related Information

• Primary Sponsor: Fushimi Masahiko
• Secondary Sponsor: Mochida Pharmaceutical Co., Ltd.