An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Carpal Tunnel Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 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 Synera for the treatment of pain associated with mild to moderate carpal tunnel syndrome.
详细描述
ZARS Pharma, Inc. has developed Synera® (lidocaine 70 mg and tetracaine 70 mg topical patch), a drug delivery patch that utilizes controlled heat to enhance the delivery of a local anesthetic formulation consisting of a eutectic mixture of lidocaine and tetracaine. Synera was approved by the Food and Drug Administration (FDA) on June 23, 2005 and is indicated for use on intact skin to provide local dermal analgesia for superficial venous access and superficial dermatological procedures such as excision, electrodesiccation, and shave biopsy of skin lesions.
The purpose of this single center, 2-week open-label pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with mild to moderate CTS.
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 mild to moderate carpal tunnel syndrome in a single wrist
- •Have recent (within 3 months) electrodiagnostic evidence of carpal tunnel syndrome (CTS)
排除标准
- •Have bilateral carpal tunnel syndrome
- •Have another peripheral neuropathy in the affected limb
- •Have had an injection into the carpal tunnel within 8 weeks
- •Have had surgical release of the target wrist within previous 6 months
- •Have electrodiagnostic evidence of severe CTS
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Synera
Synera topical patch
干预措施: Synera (lidocaine 70 mg and tetracaine 70 mg) topical patch (Drug)
结局指标
主要结局
Pain intensity
时间窗: Screening/Day 1, Day 8, and Day 15 or early withdrawal
次要结局
- Pain interference with activities (general, normal work, sleep)(Screening/Day 1, Day 8, and Day 15 or early withdrawal)