Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale
研究概览
简要总结
Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults from 18 to 75 years old
- •neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months
- •Exclusion criteria:
- •cardiovascular risk
- •unstable diabetes mellitus
- •allergy for terbutaline
- •hypokaliemia without treatment
- •untreated hypothyroidism
- •HIV- or chemotherapy-induced neuropathy
- •cancer being treated by chemo- or radio-therapy
- •concomitant treatment with β-blockers, tricyclic ADs or morphine
- •concomitant pain more severe than neuropathic pain- pregnant women
排除标准
- 未提供
研究组 & 干预措施
first period with terbutaline and second period with placebo
The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.
干预措施: Terbutaline sustained release 5 mg (Drug)
first period with placebo and second period with terbutaline.
The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods.
干预措施: Terbutaline sustained release 5 mg (Drug)
结局指标
主要结局
Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale
时间窗: Day one, day 14 and day 28 of each 4 weeks period
次要结局
未报告次要终点