TMX-67 Pediatric Phase 2 Study

Phase 2

Completed

• Conditions: Hyperuricemic pediatric patients with or without gout

• Registration Number: JPRN-jRCT2080224846
• Lead Sponsor: Teijin Pharma Limited

Brief Summary

In pediatric patients with hyperuricemia including gout who received 34-week multiple oral doses of TMX-67, efficacy, safety, and pharmacokinetics were investigated in an open-label and uncontrolled design. As a result, the primary outcome was successfully achieved, demonstrating that TMX-67 may have efficacy also in pediatric patients with hyperuricemia including gout. No significant safety concern was identified.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-23
• Study Completion: 2021-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Hyperuricemic pediatric patients with or without gout

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified