EUCTR2009-016458-42-GB进行中（未招募）1 期
A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZA plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy - PACE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 468
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
- •2. Male or female >18 years of age
- •3. Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes
- •4. Stable glycemic control for at least 6 months prior to screening visit
- •5. Average Numeric Pain Rating Scale (NPRS) score over the last 24 hours of >4 at the screening and the baseline visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 270
排除标准
- •1. Primary pain associated with PDPN in the ankles or above
- •2. Pain that could not be clearly differentiated from, or conditions that might interfere with, the assessment of PDPN
- •3. Significant pain (moderate or above) of an etiology other than PDPN, that may interfere with judging PDPN-related pain
- •4. 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.
- •5. Hypersensitivity to capsaicin (i.e., chili peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients, EMLA ingredients or adhesives
研究者
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