An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
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 the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome
详细描述
The purpose of this single center, 2-week open-label 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 shoulder impingement syndrome. 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
- •Pain associated with shoulder impingement syndrome in a single shoulder
- •Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
- •Have positive Hawkins and Neers signs
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 injected pain medication within 14 days preceding the Screening/Baseline visit
- •Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
- •Have a history of and/or past diagnosis of severe hepatic disease
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Heated lidocaine/tetracaine topical patch
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
干预措施: Heated lidocaine and tetracaine topical 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 (general, normal work, and sleep)(Two weeks)