The Qutenza® Patch for Disabling Treprostinil Infusion Site Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Pain Score on a Visual Analogue Scale
研究概览
简要总结
Subcutaneous treprostinil (Remodulin) is effective therapy for pulmonary arterial hypertension, a life threatening disease of the lung blood vessels. Unfortunately, treprostinil is irritating to the skin and many patients experience intense pain at the infusion site for the first 7-10 days after placing a new subcutaneous infusion site.
Qutenza is an FDA approved formulation of 8% capsaicin that is approved for the treatment of post-herpetic neuralgia, a painful skin condition. The investigators hypothesize that pretreatment of an area of skin with Qutenza would decrease the pain associated with a new treprostinil infusion site. The investigators hope that Qutenza will decrease both the intensity of the pain and the duration of the pain after patients place a new treprostinil infusion site.
In this initial study, the investigators will provide Qutenza in open-label, unblinded fashion and ask patients to rate their pain using a diary tool with which they are already comfortable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pulmonary Hypertension
- •Using subcutaneous treprostinil
- •Already participating as a subject in our prospective study of infusion site pain
- •Has documented debilitating pain (6/10 or greater) in the study after a site change
排除标准
- •Uncontrolled hypertension
- •Recent stroke or myocardial infarction
研究组 & 干预措施
Qutenza patch
All participants actively treated with Qutenza
干预措施: Qutenza (8% capsaicin) (Drug)
结局指标
主要结局
Pain Score on a Visual Analogue Scale
时间窗: 14 days after a new infusion site
Patients will record the maximum intensity of pain (0-10) each day after placing an infusion site in a diary with which they are already comfortable. They will record the score each day for 14 days unless they have recorded "0" for two consecutive days. The primary outcome measure will be the average of those 14 maximum intensity pain scores (the sum of the maximum for each day divided by the number of days, generally 14; range 0-10).
次要结局
- Number of Participants Who Experienced Greater Than 6 Pain Level Using the 10 Point Visual Analog Score(60 minute period of patch application and subsequent 3 days)
- Number of Participants Who Used of Narcotics Following a Treprostinil Infusion Site Change(14 days)
研究者
R. James White
Professor
University of Rochester