A Phase II Randomized, Double Blind, Parallel Group, Placebo-Controlled Dose Finding and Efficacy Study of VPD-737 in the Treatment of Subjects With Chronic Pruritus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 25
- 主要终点
- Visual Analog Scale
研究概览
简要总结
A study of a several doses of a novel treatment for chronic itch compared to placebo for patients whose condition has not responded to other treatments
详细描述
The sensation of itch is transmitted to the brain through the nervous system Several chemicals are involved in transmitting this signal This trial of VPD 737 is intended to treat this condition by blocking one of the chemicals involved in the transmission of the itch signal This is an oral drug administered once daily It has been used in other trials and has shown to be safe at the doses used in this trial The trial will involve once daily pills for 6 weeks. Subject will be asked to fill out questionnaires both electronically and on paper during the study period Patients will also be monitored for safety and will have blood taken for testing and several points during the trial Overall participation will last about 12 weeks
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic pruritus and unresponsive to current therapies
排除标准
- •Have chronic liver or renal disease
研究组 & 干预措施
0.25 mg VPD-737
0.25 mg of VPD-737 daily by mouth for 42 days
干预措施: VPD-737 (Drug)
1 mg VPD-737
1 mg VPD-737 taken daily by mouth for 42 days
干预措施: VPD-737 (Drug)
5 mg VPD-737
5 mg tablets of VPD-737 to be taken daily by mouth for 42 days
干预措施: VPD-737 (Drug)
Placebo
placebo tablets to be taken daily by mouth for 42 days
干预措施: Placebo (Drug)
结局指标
主要结局
Visual Analog Scale
时间窗: 6 weeks
次要结局
- Verbal Response Scale(6 weeks)