A Phase II, Randomized, Double Blind, Placebo-controlled, Multicenter Study to Investigate the Impact of NP2 in Subjects With Intractable Pain Due to Malignancy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Diamyd Inc
- 入组人数
- 33
- 试验地点
- 36
- 主要终点
- Pain Measured by the Numerical Rating Scale (NRS)
研究概览
简要总结
The purpose of this study is to examine the impact of intradermal delivery of NP2 on pain scores and pain medication usage in subjects with intractable pain due to malignant disease. A second purpose is to confirm safety and secondary efficacy measurements.
详细描述
Chronic severe pain remains a significant unmet medical need in patients that have progressive cancer. Existing treatments have limited efficacy and also suffer significant side effects. This is a multi-center, randomized, double blind, placebo-controlled clinical trial designed to evaluate the impact of intradermal injection of NP2 in subjects who have intractable pain due to malignant disease. NP2 is a gene transfer vector engineered to express human preproenkephalin, a gene naturally involved in pain control. Delivery of NP2 directly to the site of pain caused by cancer is intended to provide increased Enkephalin peptides, which bind to opioid receptors, that may allow better pain control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed malignant disease.
- •Intractable pain related to malignancy.
- •Females must be postmenopausal or practicing birth control.
- •Able to provide appropriate written consent.
排除标准
- •Positive pregnancy test prior to receiving study treatment.
- •Serious uncontrolled medical condition other than malignancy (e.g. congestive heart failure, coagulopathy, uncontrolled diabetes).
- •Evidence of active Hepatitis B, Hepatitis C, or HIV infection.
- •Evidence of viral, bacterial, or fungal infection in the planned treatment area.
结局指标
主要结局
Pain Measured by the Numerical Rating Scale (NRS)
时间窗: Days -5 to -1 predosing and days 3 to 14 postdosing
• Change from baseline of the average daily NRS pain score (scale of 0 to 10 ) of Placebo compared to Active NP2 cohorts.
次要结局
- Opioid Pain Medication Usage Morphine Equivalent Units (MEU)(Days -5 to -1 predosing and 3 to 14 postdosing)
- Pain SF-MPQ(Baseline and Week 1, 2 and 4)
- Quality of Life ECOG(Baseline and Week 1, 2 and 4)
- Quality of Life SF-12(Baseline and Week 1, 2 and 4)