A Randomized, Double-Blind, Placebo-Controlled, Parallel, 3-Arm Study of the Safety and Anti-Pruritic Efficacy of Nalbuphine HCl ER Tablets in Prurigo Nodularis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
研究概览
简要总结
The primary objectives of the study are 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 patients with prurigo nodularis 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject suffering from generalized prurigo nodularis
- •Have demonstrated pruritus intensity during screening
- •Male or female who are at least 18 years old at the time of consent
排除标准
- •Subject has chronic pruritus resulting from other conditions
- •Subject has a history of substance abuse within the past year
- •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 90mg
nalbuphine HCl ER tablets 90 mg BID
干预措施: nalbuphine HCl ER tablets 90 mg BID (Drug)
nalbuphine HCl ER 180 mg
nalbuphine HCl ER tablets 180 mg BID
干预措施: nalbuphine HCl ER tablets 180 mg 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 Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
时间窗: Baseline, Week 10
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
次要结局
- Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale(Baseline, Week 10)