Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 691
- 主要终点
- Daily Average Pain Scores
研究概览
简要总结
A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.
详细描述
A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.
排除标准
- •The patients were excluded according to the current Summary of Product Characteristics.
研究组 & 干预措施
Patients with neuropathic pain
干预措施: Pregabalin (Drug)
结局指标
主要结局
Daily Average Pain Scores
时间窗: Baseline, Final Visit (Week 8 or discontinuation)
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Daily average pain score is measured using a 10-point Likert scale where 0 = no pain to 10 = pain as bad as you can imagine.
Pain Related Sleep Interference
时间窗: Baseline, Final Visit (Week 8 or discontinuation)
Change is observed value at final visit (Week 8 or discontinuation) minus baseline value. Pain related sleep interference is measured by a 10-point Likert scale where 0 = does not interfere with sleep, and 10 = completely interferes with sleep
次要结局
- Anxiety and Depression Symptoms(Baseline, Final Visit (Week 8 or discontinuation))
- Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)(Final Visit (Week 8 or discontinuation))
- Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)(Final Visit (Week 8 or discontinuation))