A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Hemodialysis Patients With Uremic Pruritus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 373
- 试验地点
- 45
- 主要终点
- Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
研究概览
简要总结
The primary objectives of the study to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in hemodialysis patients with moderate to severe uremic pruritus and to evaluate the safety and tolerability in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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 has been receiving in-center hemodialysis for ≥ 3 months and are currently on a schedule of 3 times a week.
- •Subject self-categorized themselves on the Patient Assessed Disease Severity Scale during Screening
- •Subject meets standard of care hemodialysis efficiency guidelines during the three months prior to completing Screening
- •Have demonstrated pruritus intensity on the Itch NRS during screening
- •Male or female who are at least 18 years old at the time of Screening
排除标准
- •Subject had a significant alteration in dialysis regimen during the Screening Period
- •Subject receiving or anticipated to be receiving nocturnal dialysis or home hemodialysis treatment during the study.
- •Subject has pruritus that is believed to be caused by a condition unrelated to end-stage renal disease
- •Has had a history of substance abuse within 6 months prior to completing Screening
- •Subject has a known drug allergy to opioids
- •Subject is a pregnant or lactating female.
研究组 & 干预措施
nalbuphine HCl ER 60mg
nalbuphine HCl ER tablets 60 mg BID
干预措施: nalbuphine HCl ER tablets 60 mg BID (Drug)
nalbuphine HCl ER 120mg
nalbuphine HCl ER tablets 120 mg BID
干预措施: nalbuphine HCl ER tablets 120mg BID (Drug)
Sugar pill
Placebo tablets BID
干预措施: Placebo tablets BID (Drug)
结局指标
主要结局
Change From Baseline to the Evaluation Period in Itch on the 0-10 Itch Numerical Rating Scale
时间窗: 8 weeks
The evaluation period was defined as the average itch score over weeks 7 and 8 following initiation of treatment. A negative change form baseline (Evaluation Period - Baseline) signified inmprovement.
次要结局
未报告次要终点