NCT01701362已完成3 期
A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Pregabalin (Bid) In Subjects With Post-traumatic Peripheral Neuropathic Pain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.149 个研究点 分布在 1 个国家目标入组 542 人开始时间: 2012年10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
- 542
- 试验地点
- 149
- 主要终点
- Change From Baseline to Week 15 in Weekly Mean Pain Score
研究概览
简要总结
This study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
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 must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.
- •Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone in order to complete the IVRS assessments each day, perform telephone visits and complete all required assessments/forms.
- •Subjects must have sufficient post-traumatic neuropathic pain at screening and baseline.
排除标准
- •Subjects with neuropathic pain due to diabetic peripheral neuropathy (DPN), post herpetic neuralgia (PHN), HIV, trigeminal neuralgia (TGN), carpal tunnel syndrome (CTS) or with central neuropathic pain (for example, due to spinal cord injury) or with Complex Regional Pain Syndrome (CRPS, Type I or Type II).
- •Subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain.
- •Subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening.
- •Subjects with epilepsy; pernicious anemia; hematological illnesses; known HIV infection; any clinically unstable cardiovascular (including a myocardial infarction [heart attack] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis B, hepatitis B within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism.
- •Subjects with a diagnosis of DSM-IV TR Axis I disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of Generalized Anxiety Disorder (GAD) or major depression that is clinically stable.
- •Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
- •Use of prohibited medications in the absence of appropriate washout periods.
研究组 & 干预措施
pregabalin
Active Comparator
干预措施: pregabalin (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 15 in Weekly Mean Pain Score
时间窗: up to Week 15
This is based on the daily pain diary and is defined as the change from baseline to week 15 in mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
Baseline Mean Pain Score
时间窗: Baseline
This is based on the daily pain dairy and is defined as the baseline mean pain diary score. The Daily Pain Diary consists of an 11-point numeric rating scale (NRS) ranging from 0 ("no pain") to 10 ("worst possible pain"). Subjects describe their pain during the past 24 hours by choosing the appropriate number between 0 and 10.
次要结局
- Patient Global Impression of Change (PGIC) at Week 15(Week 15)
- Change From Baseline to Endpoint in Quality of Life Using EuroQol (EQ-5D) Health State Profile Scores(Week 15)
- Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥30%.(Week 15)
- Change From Baseline in Overall Weekly Mean Sleep Interference Score (SIRS)(up to Week 15)
- Change From Baseline in Pain Interference Index (BPI-sf)(Week 15)
- Baseline Scores in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.(Baseline)
- Change From Baseline in Pain Severity Index (Brief Pain Inventory-short Form [BPI-sf])(Week 15)
- Mean Change From Baseline in the Medical Outcomes Study Sleep Scale (MOS-SS) - Sub-domain Score.(Week 15)
- Percentage of Participants in MOS-SS With Optimal Sleep Status.(Week 15)
- Percentage of Responders to Treatment With Pregabalin Measured as Reduction in Mean Pain Score of ≥50%(Week 15)
研究者
研究点 (149)
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