Clinical Neuropharmacology of Pain in Spinal Cord Injury- Dextromethorphan Dose Response 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
- Mean Pain Intensity (Percent Change From Baseline)
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 three doses of chronic oral (PO) dextromethorphan compared to placebo in central neuropathic pain following spinal cord injury. Subjects' maximally tolerated doses (MTD) were first determined to establish individual dose-analgesic response relationships in a run-in period; following a washout period, subjects were then randomized to receive an order of four doses of dextromethorphan (including placebo) in a 4x4 Latin square cross-over design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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:
- •Liver function tests (albumin within 20% of normal, SGOT/SGPT within 50% of normal).
- •For women of childbearing age: negative serum beta HCG.
- •Postmenopausal women, or be physically incapable of childbearing, or be practicing an acceptable method of birth control.
- •Normal cognitive function.
- •Normal communicative ability (English).
- •Ability to demonstrate competence in recording five times daily in pain diary for 1 week (with 100% compliance), and in completing required questionnaires.
- •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.
- •Concurrent use of monoamine oxidase inhibitors within 2 weeks prior to study entry.
- •Use of known CYP2D6 (but not CYP3A4) inhibitors or inducers.
- •History of hypersensitivity or intolerance to dextromethorphan or lidocaine.
- •Chronic substance abuse, including alcohol.
- •Participation in a study of an investigational drug or device within 30 days prior to screening for this study.
- •Poor metabolizer of P450 2D6 substrates.
研究组 & 干预措施
0% MTD Dex
0% MTD Dextromethorphan
干预措施: Dextromethorphan (Drug)
25% MTD Dex
25% MTD Dextromethorphan
干预措施: Dextromethorphan (Drug)
50% MTD Dex
50% MTD Dextromethorphan
干预措施: Dextromethorphan (Drug)
100% MTD Dex
100% MTD Dextromethorphan
干预措施: Dextromethorphan (Drug)
结局指标
主要结局
Mean Pain Intensity (Percent Change From Baseline)
时间窗: 1st week of maintenance period (week prior to hospital admission for nested study; subjects traveled to Boston on days 6-7 of the maintenance period)
Primary outcome was percent change from baseline in mean pain intensity (transformed Gracely Scale; 0-35). Baseline was defined as the week prior to randomization. The greater the percent change, the bigger the reduction in pain intensity.
次要结局
- Satisfaction(Last week prior to admission (end of 1-week maintenance period))
研究者
Christine N. Sang, MD, MPH
Director, Translational Pain Research
Brigham and Women's Hospital