Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
研究概览
简要总结
The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.
详细描述
The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups:
- Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow
- Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
- Naproxen Sodium: 500mg bid
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
- •Age 18 or higher
- •Minimum of 4 on Question 5 of BPI
排除标准
- •Peripheral neuropathy of any origin in the index limb
- •Cubital tunnel syndrome in patients with medial epicondylitis
- •Cortisone injection in the last 4 weeks into the index limb
- •Surgical intervention in the past for the epicondiitis
- •Participants in any other clinical trial in the last 30 days
- •Known allergy to lidocaine, tetracaine, NSAIDs or PABA
- •Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator
- •Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias
- •Patients who are pregnant, lactating or breast feeding
- •Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.
研究组 & 干预措施
Synera sinlgle patch applied for 4hrs twice daily
干预措施: Synera patch twice daily (Drug)
Synera sinlgle patch applied for 4hrs twice daily
干预措施: Synera (Drug)
Naproxen
干预措施: Naproxen (Drug)
Synera single patch applied for 12 hrs/day
干预措施: Synera patch for 12hrs/day (Drug)
Synera single patch applied for 12 hrs/day
干预措施: Synera (Drug)
结局指标
主要结局
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
时间窗: Day 1 and Day 14
Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit
次要结局
- Pain quality assessment scale(Every visit from the entry)