NCT00292188已完成4 期
A 9 Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Study Of Pregabalin (BID) In Subject With Posttraumatic Peripheral Neuropathic Pain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
研究概览
简要总结
To evaluate the efficacy of pregabalin compared to placebo in the treatment of posttraumatic peripheral neuropathic pain
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of Posttraumatic Peripheral Neuropathic Pain (NeP) syndrome, including post-surgical NeP, NeP due to peripheral nerve injury, and phantom limb pain, confirmed by a qualified pain specialist and persisting for a minimum of 3 months following the traumatic event
排除标准
- •Subjects whose posttraumatic neuropathic pain is due to Complex Regional Pain Syndrome (CRPS, Type I or Type II)
- •NeP not due to trauma, and not peripheral pain
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Active
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Weekly Mean Pain Score at End of Treatment (Week 8) From Daily Pain Diary
时间窗: each day of Week 8
Daily Pain Diary scale : mean score from 11-point numerical scale of pain; range: 0 (no pain) to 10 (worst possible pain). Endpoint weekly mean pain score: mean of the last 7 available pain scores from a daily pain diary during double blind treatment.
次要结局
- Hospital Anxiety and Depression Scale (HADS) Depression Score - FAS Subset With Moderate/Severe Baseline Scores(Week 8)
- Number of Subjects With 30% and 50% Response in Weekly Mean Daily Pain Rating Score (DPRS) From Baseline Until Endpoint (Week 8)(Baseline, Week 8)
- Hospital Anxiety and Depression Scale (HADS) Anxiety Score(Week 8)
- Hospital Anxiety and Depression Scale (HADS) Anxiety Score - FAS Subset With Moderate/Severe Baseline Scores(Week 8)
- Clinical Global Impression of Change (CGIC)(Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Attention(Baseline, Week 8)
- Medical Outcome Study (MOS) Sleep Subscales(Week 8)
- Patient Global Impression of Change (PGIC)(Week 8)
- Pain Treatment Satisfaction Scale (PTSS): Efficacy(Screening, Week 8)
- Modified Brief Pain Inventory Short Form (m-BPI-sf)(Baseline, Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Thinking(Baseline, Week 8)
- Davidson Trauma Scale (DTS): Severity(Baseline, Week 8)
- Davidson Trauma Scale (DTS): Frequency(Baseline, Week 8)
- Davidson Trauma Scale (DTS): Total Score(Baseline, Week 8)
- Hospital Anxiety and Depression Scale (HADS) Depression Score(Week 8)
- Weekly Mean Pain Score From Daily Pain Diary(Baseline through Week 8)
- Weekly Mean Sleep Interference Score(Week 8)
- Medical Outcome Study (MOS) Optimal Sleep(Week 8)
- Neuropathic Pain Symptom Inventory (NPSI) Total Intensity Score(Week 8)
- Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication(Screening, Week 8)
- Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication(Screening, Week 8)
- Pain Treatment Satisfaction Scale (PTSS): Medication Characteristics(Screening, Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Concentration(Baseline, Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Reasoning(Baseline, Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Confusion(Baseline, Week 8)
- Medical Outcome Study Cognitive Subscale (MOS-Cog); Memory(Baseline, Week 8)
研究者
研究点 (1)
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