Randomised, Double-blind, Placebo-controlled Trial of the Effect of the Combination of Imipramine and Pregabalin for the Treatment of Painful Polyneuropathy
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 3
- 主要终点
- Total pain intensity as measured by numeric rating scale 0-10 points.
研究概览
简要总结
Polyneuropathy of different etiologies is often associated with pain and the standard treatment for this type of pain is gabapentinoids or antidepressants. The hypothesis of this study is that the combination of the gabapentinoid pregabalin and the antidepressant imipramine will provide better pain relief than the single compounds alone.
This is a randomized, placebo-controlled, double-blind, 4-way, cross-over trial of pregabalin 300 mg/day, imipramine 75 mg/day and their combination versus placebo. The study will include 60 patients and the treatment outcome will be pain intensity as measured by numeric rating scales.
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
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 - 85 years.
- •Characteristic symptoms of polyneuropathy for at least 6 months.
- •Polyneuropathy diagnosis confirmed by typical clinical signs (distal sensory disturbance/lack of distal deep tendon reflexes) and/or electrophysiological tests and/or abnormal quantitative sensory tests.
- •Total pain intensity rating of at least 4 on a 0-10 points numeric rating scale.
- •Pain present at least 4 days a week.
- •For diabetics: diabetes diagnosis for at least 6 months and stable metabolic control for at least 3 months.
- •For other secondary polyneuropathies: stable for at least 6 months.
- •For fertile females: adequate anticonceptive treatment.
- •Written informed consent.
排除标准
- •Other cause of pain.
- •Contraindications against imipramine.
- •Allergic reactions towards imipramine or pregabalin.
- •Known adverse reactions during imipramine or pregabalin treatment.
- •Pregnancy.
- •Severe systemic disease.
- •Ongoing treatment with antidepressants, antipsychotics, anticonvulsants, opioids, propranolol, kinidine, monoamine oxidase inhibitor.
- •Inability to follow study protocol.
研究组 & 干预措施
Imipramine
Imipramine tablets and placebo capsules to pregabalin
干预措施: Imipramine (Drug)
Pregabalin
Pregabalin capsules and placebo tablets to imipramine
干预措施: Pregabalin (Drug)
Imipramine plus pregabalin
Imipramine tablets and pregabalin capsules
干预措施: Imipramine, pregabalin (Drug)
Placebo
Placebo tablets to imipramine and placebo capsules to pregabalin
干预措施: Placebo (Drug)
结局指标
主要结局
Total pain intensity as measured by numeric rating scale 0-10 points.
时间窗: Median of ratings from last week of each treatment period
次要结局
- Verbal pain relief scale with 6 classes(End of each treatment period)
- Specific pain symptom rated by numeric rating scales 0-10 points(Median of ratings from last week of each treatment period)
- Rating of evoked pains symptoms (pressure, brush, repetitive pin-prick, cold) as measured by numeric rating scales 0-10 points(End of each treatment period)
- Sleep disturbance as measured by numeric rating scale 0-10 points(Median of ratings from last week of each treatment period)
- Consumption of escape medication (number of tablets of paracetamol)(Total consumption during last week of each treatment period)
- Health related quality of life (SF-36)(End of each treatment period)
- Major Depression Inventory (MDI)(End of each treament period)