A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM Plus Standard of Care Versus Standard of Care Alone in Subjects With Painful Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 64
- 主要终点
- Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
研究概览
简要总结
The purpose of the study is to assess the safety of repeated applications of QUTENZA in reducing pain intensity in subjects who have peripheral neuropathic pain due to diabetes.
详细描述
Patients will be divided into 3 groups of approximately equal size. In the first group, patients will receive a QUTENZA patch applied for 30 minutes to the feet; in the second group, patients will receive a QUTENZA patch applied for 60 minutes to the feet. In both these groups patients will also continue to receive their normal treatment (Standard of Care (SOC)) for their peripheral neuropathic pain (PNP) and may receive further QUTENZA patch applications in the same way during the study. The third group will not receive a QUTENZA patch but will continue to receive their normal treatment for their neuropathic pain (SOC). Subjects will be involved in the study for up to 15 months and will have to visit the clinic at least 9 times.
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
- Single (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
- •Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
- •Stable glycemic control for at least 6 months prior to screening visit
- •Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit
排除标准
- •Primary pain associated with PDPN in the ankles or above
- •Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
- •Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
- •Female subjects of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain highly effective birth control during the study.
- •Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, Eutectic Mixture of Local Anesthetics( EMLA) ingredients or adhesives
研究组 & 干预措施
1. Qutenza 30 minutes + SOC
干预措施: QUTENZA (Drug)
2. Qutenza 60 minutes + SOC
干预措施: QUTENZA (Drug)
结局指标
主要结局
Percentage change in health related quality of life (HRQOL) total score as assessed by the disease specific Norfolk scale
时间窗: Baseline till endpoint (discontinuation or End of Study visit) (up to 64 weeks)
次要结局
- Tolerability of patch application by dermal assessment(Screening till Last visit when QUTENZA patch is applied (up to 53 weeks))
- Adverse Events and serious adverse Events(Screening visit through End of study visit (up to 65 weeks))
- Laboratory Analyses(Screening visit through End of study visit (up to 65 weeks))
- Intensity of neuropathic pain using "average pain" NPRS scores(Screening visit through End of study visit (up to 65 weeks))
- Brief Pain Inventory (BPI) pain severity index and pain interference index(Screening visit through End of study visit (up to 65 weeks))
- Patient Global Impression of Change(After each patch re-application, from first patch re-application through End of Study visit (up to 56 weeks))
- Generic HRQOL measured by European Quality of Life - 5 Dimensions (EQ-5D) questionnaire(After each patch application, from first patch application through End of Study (up to 64 weeks))
- Treatment satisfaction using the Self-Assessment of Treatment (SAT) questionnaire at week 12/End Of Study visit(End of Study (up to 65 weeks))
- Neurological function as assessed by the Utah Early Neuropathy Scale (UENS) and sensory testing(Baseline till End of Study (up to 64 weeks))
- Tolerability of patch application by rescue medication use(Days 1 through 5 after each patch application)
- Vital Signs (heart rate and blood pressure)(Screening visit through End of study visit (up to 65 weeks))
- Tolerability of patch application by "pain now" Numeric Pain Rating Scale (NPRS) scores after patch application(Baseline till Last visit when QUTENZA patch is applied (up to 52 weeks))