Phase 4 Study of Tapentadol vs Oxycodone in Neuropathic Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Mechanical Pain Threshold (MPT)
研究概览
简要总结
The purpose of this study is to elucidate whether the additional mechanism of analgesia, i.e. reuptake inhibition of norepinephrine, of tapentadol leads to a change in different pain signs and symptoms in comparison to oxycodone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •thermal or mechanical hyperalgesia
- •chronic neuropathic pain (NRS => 6)
排除标准
- •non-specific
研究组 & 干预措施
oxycodone
干预措施: tapentadol, oxycodone (Drug)
tapentadol
干预措施: tapentadol, oxycodone (Drug)
结局指标
主要结局
Mechanical Pain Threshold (MPT)
时间窗: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Mechanical Pain Threshold from baseline to V6 The mechanical pain threshold (MPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Heat Pain Threshold (HPT)
时间窗: day 0 (baseline) and day 78 (10 weeks)
Change of Heat Pain Threshold from V1 to V6 The was Heat Pain Threshold (HPT)measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Wind-Up Ratio (WUR)
时间窗: day 0 (baseline) and day 78 (10 weeks)
Change of Wind-Up Ratio from V1 to V6 The Wind-Up Ratio (WUR) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Cold Pain Threshold (CPT)
时间窗: day 0 (baseline) and day 78 (10 weeks)
Change of Cold Pain Threshold from baseline to V6 The Cold Pain Threshold (CPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Pressure Pain Threshold (PPT)
时间窗: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Pressure Pain Threshold from V1 to V6 The Pressure Pain Threshold (PPT) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Mechanical Pain Sensitivity (MPS)
时间窗: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Mechanical Pain Sensitivity from V1 to V6 The Mechanical Pain Sensitivity (MPS) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. Logarithmically transformed raw data were z-transformed by subtracting the mean value of the corresponding reference group followed by a division the respective standard deviation. If the resulting z-value exceeds 1.96, it is outside the 95% confidence interval of the standard normal distribution with zero mean and unit variance, independent of the original units of measurement. (also see Rolke et. al.) A lower z-value indicates an improvement.
Dynamic Mechanical Allodynia (DMA)
时间窗: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of Dynamic Mechanical Allodynia from V1 to V6 The Dynamic Mechanical Allodynia (DMA) was measured according to the established protocol of Deutscher Forschungsverbund Neuropathischer Schmerz (DFNS). "Subjects were asked to give a pain rating for each stimulus on a '0-100' numerical rating scale ('0' indicating "no pain", and '100' indicating "most intense pain imaginable")." See Rolke, R et al. "Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values." Pain vol. 123,3 (2006): 231. A lower score indicates an improvement.
Pain Upon Numeric Rating Scale
时间窗: day 0 (baseline) and day 78 (V6; 10 weeks)
Change of pain upon Numeric Rating Scale (NRS; 0 = no pain at all; 10 = maximum pain imaginable) from V1 to V6
次要结局
- Cold Detection Threshold (CDT)(day 0 (baseline) and day 78 (10 weeks))
- Warmth Detection Threshold (WDT)(day 0 (baseline) and day 78 (V6; 10 weeks))
- Thermal Sensory Limen (TSL)(day 0 (baseline) and day 78 (V6; 10 weeks))
- Mechanical Detection Threshold (MDT)(day 0 (baseline) and day 78 (V6; 10 weeks))
- Vibration Detection Threshold (VDT)(day 0 (baseline) and day 78 (V6; 10 weeks))
- Paradoxical Heat Sensations (PHS)(day 0 (baseline) and day 78 (V6; 10 weeks))
研究者
Ralf Baron
Prof. Dr. med.
University Hospital Schleswig-Holstein