Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA (NI-PMS)
2021年1月21日 更新者：Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
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.
研究概览
详细说明
A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks
研究类型
观察性的
注册 (实际的)
691
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with neuropathic pain
描述
Inclusion Criteria:
- Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.
Exclusion Criteria:
- The patients were excluded according to the current Summary of Product Characteristics.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients with neuropathic pain
|
Capsules, 150 - 600 mg/day, 2-3 times/day, 8 weeks
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Daily Average Pain Scores
大体时间：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.
|
Baseline, Final Visit (Week 8 or discontinuation)
|
|
Pain Related Sleep Interference
大体时间：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
|
Baseline, Final Visit (Week 8 or discontinuation)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Anxiety and Depression Symptoms
大体时间：Baseline, Final Visit (Week 8 or discontinuation)
|
The presence of anxiety and depression symptoms were measured, based on how often the subject felt a certain emotion over the past week.
Q1:Have you felt calm and relaxed?
Q2: Have you felt full of energy?
Q3: Have you felt discouraged and sad?
Final Visit = Week 8 or time of discontinuation.
|
Baseline, Final Visit (Week 8 or discontinuation)
|
|
Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
大体时间：Final Visit (Week 8 or discontinuation)
|
Clinician Global Improvement of Change (CGIC) indicates the change of the severity of the condition from baseline, graded from "very much improved" to "very much worse".
|
Final Visit (Week 8 or discontinuation)
|
|
Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
大体时间：Final Visit (Week 8 or discontinuation)
|
Patient Global Improvement of Change (PGIC) indicates the change of severity of conditions from baseline, graded from "very much improved" to "very much worse".
|
Final Visit (Week 8 or discontinuation)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年9月1日
初级完成 (实际的)
2008年3月1日
研究完成 (实际的)
2008年3月1日
研究注册日期
首次提交
2009年2月12日
首先提交符合 QC 标准的
2009年2月12日
首次发布 (估计)
2009年2月13日
研究记录更新
最后更新发布 (实际的)
2021年2月10日
上次提交的符合 QC 标准的更新
2021年1月21日
最后验证
2009年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.