A Randomized Double Blind, Placebo-controlled, Dose Response Study of Intraspinal Gabapentin (MDT2004) in Subjects With Chronic, Intractable Pain.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 254
- 试验地点
- 14
- 主要终点
- Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
研究概览
简要总结
The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain below the neck present for a minimum of one year.
- •Diagnosis of at least one of the following:
- •back pain with or without leg pain,
- •post-herpetic neuralgia,
- •complex regional pain syndrome (CRPS) 1 or 2,
- •diabetic neuropathy,
- •or a general neuropathic condition; medically stable and able to undergo surgery for implantation of the drug infusion system.
排除标准
- 未提供
研究组 & 干预措施
Placebo (0mg/day)
Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
干预措施: Intraspinal Gabapentin (Drug)
Gabapentin Low (1mg/day)
Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
干预措施: Intraspinal Gabapentin (Drug)
Gabapentin Medium (6mg/day)
Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
干预措施: Intraspinal Gabapentin (Drug)
Gabapentin High (30mg/day)
Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
干预措施: Intraspinal Gabapentin (Drug)
结局指标
主要结局
Changes in a Pain Rating Scale After 3 Weeks of Blinded Treatment.
时间窗: Baseline and Post-randomization Day 22
Average pain score calculated over last 7 days of baseline minus average pain score calculated over last 7 days of follow-up using the Numeric Pain Rating Scale where 0=no pain, 10=worst possible pain.
Number of Participants With Treatment-emergent Adverse Events
时间窗: Randomization to Post-randomization Day 29 (includes dose reduction)
Evaluation of adverse event profiles between placebo and active treatment groups.
次要结局
- Responder Analysis Between Active Treatment and Placebo Groups.(Baseline to Post-randomization Day 22)