An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Victorian Institute of Sport Assessment (VISA) score
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 and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.
详细描述
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 patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.
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 pain associated with patellar tendinopathy in a single knee (minimum 2-week duration)
- •have tenderness at the proximal insertion of the patellar tendon in the affected knee
排除标准
- •have any history of surgery in the target knee
- •have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
- •have had any injected steroids in the target knee within 3 months of 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.)
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Heated Lidocaine and Tetracaine Patch
干预措施: Heated Lidocaine and Tetracaine Patch (Drug)
结局指标
主要结局
Victorian Institute of Sport Assessment (VISA) score
时间窗: Two weeks
VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study).
次要结局
- Patient Global Assessment of Treatment Satisfaction (PGAS)(Two weeks)
- Pain intensity(Two weeks)