A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Present Pain Intensity Score
研究概览
简要总结
The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.
详细描述
This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who are outpatients or inpatients
- •written informed consent obtained (signed by the subject or the subject's legally acceptable representative)
- •traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e., chronic, stage of at least 6 months duration
- •At-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance in a segmental pattern and located within two dermatomes above or below the level of spinal cord injury
- •Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features (sharp, shooting, electric or burning pain sensation) in the region of sensory disturbance located at least three dermatomes below the level of spinal cord injury
排除标准
- •spinal cord injury (subjects with central pain and musculoskeletal pain must be able to make a distinction between the two)
- •subjects who have previously not responded to 300 mg/day pregabalin: a non-responder is defined as a subject who has a reduction in pain score of less than 30% from baseline
研究组 & 干预措施
Pregabalin
干预措施: Pregabalin (Drug)
Placebo
干预措施: Placebo for pregabalin (Drug)
结局指标
主要结局
Present Pain Intensity Score
时间窗: Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)
Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
次要结局
- Punctate Allodynia Area(Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose)
- Neuropathic Pain Symptom Inventory (NPSI)(Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.)
- Pharmacokinetic Evaluations of Pregabalin(Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose)
- Dynamic Allodynia Area(Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,)
- Dynamic Allodynia Pain Score(Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose)
- Daily Pain Score(Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2))
- Mechanical Pain Sensitivity Stimulus-Response Function(Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose)