A Double-blind Placebo-controlled Study of the Efficacy and Safety of the P38 Map Kinase Inhibitor SB681323 in Patients With Neuropathic Pain Following Nerve Trauma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean average Daily Pain Intensity Numeric Rating Scale (PI-NRS) score over period
研究概览
简要总结
This will be a double-blind, placebo controlled cross-over study. After enrolment and initial assessments, subjects will receive oral SB681323 or matching placebo for 14 days. SB681323 will be administered twice daily at a total daily dose of 7.5mg. Sufficient numbers of patients will be recruited to obtain 40 evaluable patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SB681323
Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study.
干预措施: SB681323 (Drug)
Placebo
Patients with pain associated with peripheral nerve injury and/or compression will be recruited for this study.
干预措施: Placebo (Drug)
结局指标
主要结局
Mean average Daily Pain Intensity Numeric Rating Scale (PI-NRS) score over period
时间窗: Day 1 to 14 of each treatment period
Participants were asked to rate their overall pain intensity for the last 24 hours, daily before retiring to bed. This constituted the Daily Pain Score. The 11 point pain intensity numerical rating scale ranged from 0 to 10, where 0 represents "No pain" and 10 represents "Maximum pain imaginable". It was used for the subjective assessment of the pain. The score ranged from 0 to 10, where 0 represented absence of symptoms and higher score indicated more severe symptoms. The average daily pain over Week 1 (Day 7) was calculated as the mean of days 2 to 6 inclusive and for week 2 (Day 14), days 8 to 13 inclusive. Participants were instructed to record their daily pain score on a dairy card and calculations of average weekly pain scores were performed on the basis of diary cards review.
次要结局
- Mean Current pain intensity (CPI) score using PI-NRS over period(Up to Day 14 of each treatment period)
- Mean Quantitative Sensory Testing (QST) in cold pain, heat pain and warmth detection threshold on Day 14(Day 14 of each treatment period)
- Mean area of static touch allodynia(Day 1 of each treatment period)
- Mean area of dynamic touch allodynia(Day 1 of each treatment period)
- Mean intensity of static and dynamic touch allodynia(Day 1 of each treatment period)
- Number of participants with Global Impression of Change Scale scores over period(Up to Day 14 of each treatment period)
- Number of participants who used rescue medication over period(Day 1 to 14 of each treatment period)
- Latency of contact heat-evoked potential stimulator (CHEPS) in the affected and control area(Day 1 of each treatment period)
- Amplitude of CHEPS in the affected and control area(Day 1 of each treatment period)
- Number of participants with skin biopsy results(80 Days)
- Number of participants with any adverse event (AE), serious adverse event (SAE) or death(Up to Follow-up (80 Days))
- Number of participants with clinical chemistry values of potential clinical concern (PCC) during treatment period(Day 1 to Day 14 of each treatment period)
- Number of participants with hematology values of PCC during treatment period(Day 1 to Day 14 of each treatment period)
- Number of participants with vital sign values of PCC during treatment period(Day 1 to Day 14 of each treatment period)
- Number of participants with normal and abnormal (not clinically significant [NCS] and clinically significant [CS]) electrocardiogram (ECG) findings(Day 1 to Day 14 of each treatment period)
- Number of pregnancies in females of child bearing potential during treatment period(Up to Follow-up (80 days))