NCT05315479终止4 期
A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Baudax Bio1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年2月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Subjects Experiencing an AE
研究概览
简要总结
This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to <17 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 2 to <17 years of age before dosing on Day 1
- •Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia
- •Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential
- •Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent
排除标准
- •Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539
- •Have a known bleeding disorder that may be worsened with the administration of an NSAID
- •Be undergoing cardiothoracic surgery
- •Has used meloxicam within 7 days before the surgical procedure on Day 1
- •Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.
研究组 & 干预措施
N1539
Experimental
N1539 (Meloxicam IV) 0.6 mg/kg (maximum 30 mg) Q24H
干预措施: N1539 (Drug)
结局指标
主要结局
Number of Subjects Experiencing an AE
时间窗: Through study completion, approximately 28 Days
Number of study subjects who experienced an AE
次要结局
未报告次要终点
研究者
研究点 (1)
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