TMX-67 Pediatric Phase 2 Study(Extension Study)

A Multi-center, Open-label, Non-controlled Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TMX-67 after Oral Administration in Hyperuricemic Pediatric Patients with or without Gout (Extension Study)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224845

Enrollment

Registered

2019-08-23

Start date

2019-09-11

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

Hyperuricemic pediatric patients with or without gout

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 Invest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hyperuricemic pediatric patients with or without gout ,who completed the observation for 34 weeks of Study TMX-67HK-201.

Exclusion criteria

Exclusion criteria: Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study

Design outcomes

Primary

Measure	Time frame
other -	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics Safety -Adverse event -Clinical laboratory tests -Vital signs -12-lead electrocardiogram etc Efficacy -Serum urate -Percent change of serum urate from baseline -Percentage of subjects with serum urate =< 6.0 mg/dL etc Pharmacokinetics -Plasma unchanged drug concentration	—

Countries

Japan

Outcome results

None listed

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