NCT01615627撤回4 期
Hypotonic Treprostinil 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
- 撤回
- 试验地点
- 1
- 主要终点
- Daily Pain Diary
研究概览
简要总结
The investigators will test whether hypotonic (diluted) remodulin solution causes less pain than the eutonic (undiluted) solution supplied by the manufacturer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PAH by standard criteria
- •Treatment with subcutaneous remodulin infusion for at least 3 months, with stable dose for 1 month
- •Pain at infusion site (defined as > 8 on McGill Pain Questionnaire)
排除标准
- •Known pregnancy or breastfeeding
研究组 & 干预措施
Hypotonic Treprostinil Solution
Experimental
Hypotonic Treprostinil Solution
干预措施: HypotonicTreprostinil Solution (Drug)
Eutonic Treprostinil Solution
Active Comparator
Eutonic Treprostinil Solution
干预措施: Eutonic Treprostinil Solution (Drug)
结局指标
主要结局
Daily Pain Diary
时间窗: 2 weeks
次要结局
- McGill Pain Questionnaire(2 weeks)
- 6 minute walk distance(2 weeks)
- CAMPHOR quality of life questionnaire(2 weeks)
- NT-proBNP level(2 weeks)
研究者
Dr David Langleben
Chair, Cardiology Department
Jewish General Hospital
研究点 (1)
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