An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain intensity
研究概览
简要总结
The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points.
详细描述
The purpose of this pilot study is to explore the usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points. The study will consist of a 2-week, open-label treatment period followed by a 2 week follow-up period conducted at a single study site. Eligible patients must have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 identifiable myofascial trigger points. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be at least 18 years of age
- •have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 myofascial trigger points
- •have trigger points confined to the upper back, shoulder, and neck
排除标准
- •have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
- •have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
- •have used any injected pain medication with 28 days preceding the Screening/Baseline Visit
- •are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Heated lidocaine/tetracaine patch
Active
干预措施: Heated lidocaine/tetracaine patch (Drug)
结局指标
主要结局
Pain intensity
时间窗: Two weeks
次要结局
- Pain interference with activities (eg, general, normal work, sleep)(Two weeks)