A Study to Observe the Efficacy and Safety of Febuxostat in Subjects with Gout and Hyperuricemia

A Phase III, Randomized, Double-blind, Double-dummy, Multi-center Clinical Study to Observe the Efficacy and Safety of Febuxostat Compared with Allopurinol in Subjects with Hyperuricemia (Including Gout)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222060

Enrollment

594

Registered

2013-04-12

Start date

2013-04-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout, Hyperuricemia

Interventions

investigational material(s) Generic name etc : Febuxostat INN of investigational material : Febuxostat Therapeutic category code : 394 Agents for treatment of gout Dosage and Administration for Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hyperuricemia with or without a history of gout

Exclusion criteria

Exclusion criteria: An attack of acute gouty arthritis at the time of the pre-assignment visit or the pre-administration visit, or subjects less than 2 weeks after recovery from a previous attack of gouty arthritis. Severe hypertension or blood pressure not well controlled with antihypertensive agents without meeting the above criteria. Hemoglobin A1c >= 8.4% or blood glucose not well controlled with hypoglycemic agents without meeting the above criteria. Renal dysfunction. Liver dysfunction. Serious heart disease, any other serious diseases or history of drug-induced allergy.

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with serum uric acid levels =< 6.0mg/dL 24w	—

Secondary

Measure	Time frame
Mean percentage change from baseline in serum uric acid levels 24w	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026