Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan/Lidocaine Combination (Factorial Design) Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percent Change in Peak Pain Intensity
研究概览
简要总结
This randomized, placebo-controlled, double-blind 4x4 crossover clinical trial was part of a larger NIH-funded study to evaluate the analgesic efficacy of multiple dose-combinations of chronic oral (PO) dextromethorphan and intravenous (IV) lidocaine in central neuropathic pain following spinal cord injury.
详细描述
This trial has several objectives:
Primary Objective To determine which combination (dose-ratio) of dextromethorphan and lidocaine provides the best balance of pain reduction and toxicity.
Secondary Objectives include To evaluate the analgesic efficacy of both dextromethorphan and lidocaine in attenuating pain related to central nervous system sensitization, specifically spontaneous pain, mechanical allodynia, and hyperalgesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male or female adults, age 18 to 70 with central neuropathic pain for a minimum of 3 months following SCI as confirmed by neurologic evaluation, with an average pain intensity score of at least moderate over at least 50% of the day for the 7 days prior to the screening visit and over the 7 days prior to starting study medication.
- •Subjects used no medication or a stabilized medication regimen for chronic and well-controlled medical conditions
- •Serum laboratory examination obtained at study entry:
- •Normal cognitive function.
- •Signed informed consent.
排除标准
- •Pregnancy or breast-feeding.
- •Renal or hepatic dysfunction.
- •Significant cardiac disease (e.g. MI within 1 year).
- •Signs or symptoms of central neurological disorder, excluding SCI.
- •Severe psychological disorder requiring treatment.
- •History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
- •Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
研究组 & 干预措施
Placebo- 0mg/kg Lido
Placebo in combination with 0mg/kg LBM lidocaine
干预措施: Placebo (Dextromethorphan) (Drug)
Placebo- 0mg/kg Lido
Placebo in combination with 0mg/kg LBM lidocaine
干预措施: Placebo (Lidocaine) (Drug)
Placebo - 1mg/kg Lido
Placebo in combination with 1mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Placebo - 1mg/kg Lido
Placebo in combination with 1mg/kg LBM lidocaine
干预措施: Placebo (Dextromethorphan) (Drug)
Placebo - 2mg/kg Lido
Placebo in combination with 2mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Placebo - 2mg/kg Lido
Placebo in combination with 2mg/kg LBM lidocaine
干预措施: Placebo (Dextromethorphan) (Drug)
Placebo - 4mg/kg Lido
Placebo in combination with 4mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Placebo - 4mg/kg Lido
Placebo in combination with 4mg/kg LBM lidocaine
干预措施: Placebo (Dextromethorphan) (Drug)
Low Dose Dex - 0mg/kg Lido
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Low Dose Dex - 0mg/kg Lido
Low dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Placebo (Lidocaine) (Drug)
Low Dose Dex - 1mg/kg Lido
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Low Dose Dex - 1mg/kg Lido
Low dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Low Dose Dex - 2mg/kg Lido
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Low Dose Dex - 2mg/kg Lido
Low dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Low Dose Dex - 4mg/kg Lido
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Low Dose Dex - 4mg/kg Lido
Low dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Medium Dose Dex - 0mg/kg Lido
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Medium Dose Dex - 0mg/kg Lido
Medium dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Placebo (Lidocaine) (Drug)
Medium Dose Dex - 1mg/kg Lido
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Medium Dose Dex - 1mg/kg Lido
Medium dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Medium Dose Dex - 2mg/kg Lido
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Medium Dose Dex - 2mg/kg Lido
Medium dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
Medium Dose Dex - 4mg/kg Lido
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
Medium Dose Dex - 4mg/kg Lido
Medium dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
High Dose Dex - 0mg/kg Lido
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
High Dose Dex - 0mg/kg Lido
High dose dextromethorphan in combination with 0mg/kg LBM lidocaine
干预措施: Placebo (Lidocaine) (Drug)
High Dose Dex - 1mg/kg Lido
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
High Dose Dex - 1mg/kg Lido
High dose dextromethorphan in combination with 1mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
High Dose Dex - 2mg/kg Lido
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
High Dose Dex - 2mg/kg Lido
High dose dextromethorphan in combination with 2mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
High Dose Dex - 4mg/kg Lido
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Dextromethorphan (Drug)
High Dose Dex - 4mg/kg Lido
High dose dextromethorphan in combination with 4mg/kg LBM lidocaine
干预措施: Lidocaine (Drug)
结局指标
主要结局
Percent Change in Peak Pain Intensity
时间窗: 30 minutes post-infusion (Cmax)
Primary outcome was percent change from baseline in mean pain intensity at Cmax (transformed Gracely Scale; 0-35). Higher values on the Gracely scale represent greater pain intensity; the greater the percent change from baseline in mean pain intensity, the bigger the reduction in pain intensity.
次要结局
未报告次要终点
研究者
Christine N. Sang, MD, MPH
Director, Translational Pain Research
Brigham and Women's Hospital