NCT00219544已完成3 期
A Randomized, Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With 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 158 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
研究概览
简要总结
This study will measure the impact of treatment with pregabalin in adult men and women who have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
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
- Double (Participant, Investigator)
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
- •Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused by a lesion of the peripheral nervous system manifesting with sensory symptoms and signs, for at least 6 months at screening.
- •At baseline, subjects must have completed at least 4 daily pain diaries and must have a mean weekly pain score equal or greater than 4.
排除标准
- •Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy; Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other entrapment-related neuropathic pain (defined as pain associated with focal nerve lesion produced by constriction or mechanical distortion of the nerve, within a fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain syndrome (type 1 and 2); Fibromyalgia.
研究组 & 干预措施
1
Experimental
干预措施: Pregabalin (Lyrica) (Drug)
2
Experimental
干预措施: Pregabalin (Lyrica) (Drug)
3
Experimental
干预措施: Pregabalin (Lyrica) (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Neuropathic Pain in Subjects With Peripheral Neuropathic Pain Conditions During the Double-blind Phase
时间窗: 9 weeks
Pain score end of Double-Blind treatment = mean of last 7 available pain scores from daily pain diary while on Double-Blind treatment. A Daily Pain Rating Score : 11- point numerical scale ranging from 0 ("no pain") to 10 ("worst possible pain").
次要结局
- Weekly Mean Sleep Interference Scores During the Double Blind Treatment Phase(Week 9)
- Weekly Mean Pain Scores During the Double Blind Treatment Phase(Week 4 - 9)
- Change in Pain Scores During Double Blind Treatment Phase(9 weeks)
- Mean Sleep Interference Score(Week 9)
- Number of Subjects With >= 30% Reduction in Mean Pain Score During Single-blind Treatment(Week 4 (end of single-blind treatment phase))
- Mean Pain Score for Non-responders at End of Single-blind Treatment Phase(Week 4)
- Categorized Daily Pain Score(Week 9)
- Mean Pain Score for Responders at End of Single-blind Treatment Phase. Change From Baseline of Mean of Last 7 Available Pain Scores From Daily Pain Diary While on Single-blind Treatment.(Week 4)
- Time to Meaningful Increase in Pain During Double-blind Treatment Phase (Number of Participants)(Week 9)
- Weekly Mean Pain Scores During the Single-blind Treatment Phase(0 and 4 weeks)
- Weekly Mean Sleep Interference Scores During the Single-Blind Treatment Phase(0 and 4 weeks)
- Change in Sleep Interference Scores During Double Blind Treatment Phase(9 weeks)
- Intensity of Neuropathic Pain -Visual Analog Scale (NeP - VAS)(Week 4, Week 9)
- Change in Hospital Anxiety and Depression Scale Responses(Week 9)
- Change in Pain Treatment Satisfaction Scale (PTSS)(Week 9)
- Patient Global Impression of Change (PGIC) Categories by Number of Subjects(Week 9)
- Change in Modified Brief Pain Inventory (mBPI) for Pain Interference or Pain Severity.(Week 9)
- Change in Euro Quality of Life (EQ-5D) Health State Profile and Visual Analog Scale Components(Week 9)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral RadiculopathyRadiculopathyNCT00159705Pfizer's Upjohn has merged with Mylan to form Viatris Inc.276
终止
3 期
Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV NeuropathyNeuropathyNCT01049217Pfizer's Upjohn has merged with Mylan to form Viatris Inc.377
尚未招募
2 期
Effect of Pregabalin Gel in Controlling Cervical Dentin HypersensitivityDentin SensitivityNCT06417580Jesuína Lamartine Nogueira Araújo18
已完成
4 期
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic NeuralgiaPost-Herpetic NeuralgiaNCT00159666Pfizer's Upjohn has merged with Mylan to form Viatris Inc.255
已完成
3 期
A Study of the Efficacy and Safety of Pregabalin for the Treatment of FibromyalgiaFibromyalgiaNCT00645398Pfizer's Upjohn has merged with Mylan to form Viatris Inc.751