TMX-67 Pediatric Phase 2 Study

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224075

Enrollment

Registered

2018-10-02

Start date

2019-02-06

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 Inve

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hyperuricemic pediatric patients with or without gout

Exclusion criteria

Exclusion criteria: -Patients who have gouty arthritis -Patients who have the history of malignant tumor in the past 5 years -Patients who have severe hepatic insufficiency -Patients who have severe renal insufficiency -Patients who have poor blood pressure control -Patients who have poor glycaemic control etc

Design outcomes

Primary

Measure	Time frame
efficacy Percentage of subjects with serum urate =<6.0 mg/dL at Week 26	—

Secondary

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

Countries

Japan

Outcome results

None listed

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