JPRN-jRCT2080224846已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6age old 至 <= 18age old（—）
- 性别
- All
入选标准
- •Hyperuricemic pediatric patients with or without gout
排除标准
- •-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
研究者
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