NCT02143973已完成2 期
An Open Label Extension Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 34
- 主要终点
- Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The primary objective of the study is to evaluate the overall safety of nalbuphine HCL ER tablets during a treatment period of up to 24 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject completed participation in the TR02 study
- •Subject is currently receiving in-center hemodialysis at the time of consent
排除标准
- •Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study
- •Subject received opiates on a daily basis during the 1 week prior to screening
- •Other than the TR02 Study Drug, Subject received any investigational drug within 4 weeks prior to Screening
- •Subject is a pregnant or lactating female
研究组 & 干预措施
nalbuphine HCl ER
Experimental
nalbuphine HCl ER titrated from a dose of 30 mg QD to 120 BID for up to 3 weeks based on tolerability and efficacy, then maintained for an additional 21 weeks. Total duration of 24 weeks.
干预措施: nalbuphine HCl ER (Drug)
结局指标
主要结局
Number and Percetage of Participants With Treatment Emergent Adverse Events (TEAEs)
时间窗: 24 weeks
The number of participants reporting at least one TEAE of a particular body system and preferred term are reported (incidence)
次要结局
未报告次要终点
研究者
研究点 (34)
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