Methadone in Post-Herpetic Neuralgia Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Change in baseline Pain
研究概览
简要总结
Neuropathic pain is a common condition and affecting 40 to 70% of the general population. Post-herpetic neuralgia is a condition almost complex and requires a multi modal treatment. Aim: This is a pilot proof-of-principle study designed to evaluate the use of low-dose methadone in post-herpetic neuralgia patients who remained refractory after first and second line treatment for post-herpetic neuralgia (PHN) and had indication for the association of an opioid agent to their current drug regimen.
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, Outcomes Assessor)
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
- •Patients with chronic (>6 months) symptomatic PHN
- •with visual analogical scale >40/100mm
- •use of first and second line drugs (tricyclic antidepressants, venlafaxine and gabapentinoids)
排除标准
- •Don't full the criteria above
研究组 & 干预措施
Methadone
in this arm patients will take methadone 5mg.
干预措施: Methadone (Drug)
Placebo
in this arm patients will take placebo pills.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in baseline Pain
时间窗: baseline (visit inclusion) and three moths latter
Assessing by verbal analog scale (VAS)
次要结局
未报告次要终点
研究者
Daniel Ciampi Araujo de Andrade
MD, PhD
University of Sao Paulo