NCT01433328终止4 期
Lidocaine Subcutaneous Infusion for Control of Treprostinil Related Site Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Daily Pain Diary
研究概览
简要总结
Treprostinil subcutaneous (under the skin) infusion is a very good medication for treating pulmonary arterial hypertension but infusion site pain may be very severe in some patients. The investigators plan to treat patients receiving treprostinil with a subcutaneous infusion of lidocaine (a local anesthestic) to treat the pain.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treprostinil treatment for at least 3 months
- •Severe infusion site pain
排除标准
- •Pregnancy/breastfeeding
- •Decompensated heart failure
- •Chronic liver disease
- •Abnormal electrolytes
- •Heart block (2/3 degree), sino-atrial block, idioventricular rhythm
- •Systolic systemic BP <90mmHg
- •Bradycardia HR <55
- •Adverse reaction to lidocaine or other amide local anesthestic
- •Interacting medications (anti-arrhythmics, CYP1A2 inhibitors)
研究组 & 干预措施
Lidocaine
Experimental
干预措施: Lidocaine (Drug)
Placebo
Placebo Comparator
Remodulin only
干预措施: Placebo (Drug)
结局指标
主要结局
Daily Pain Diary
时间窗: 1 week
10cm visual analogue scale (VAS) - Change in aggregated median/maximum scores over one week
Pain Questionnaire
时间窗: 1 week
Short Form McGill Pain Questionnaire - Change from baseline over one week
次要结局
- 6 minute walk(1 week)
- Lidocaine level(1 week)
- proNT-BNP(1 week)
研究者
Dr David Langleben
Chair, Cardiology Department
Jewish General Hospital
研究点 (1)
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