A Randomized, Double-Blind, Placebo-Controlled Phase II Dose-Ranging Study of the OrthoDerm Transdermal Nitroglycerin Patch for Patients With Chronic Lateral Epicondylitis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- pain-free grip strength
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness and safety of the use of low-dose nitroglycerin transdermal patches to treat pain and function in chronic tennis elbow.
详细描述
Chronic tendonitis remains difficult to treat. Nitric oxide has been demonstrated to stimulate tenocytes to proliferate, differentiate and produce matrix components including collagen. Studies have demonstrated that nitroglycerin transdermal patches, which release nitric oxide, reduce pain and increase function in patients with chronic tendonitis. The purpose of the present study is to examine the efficacy of three dose levels of nitroglycerin, compared to placebo, in reducing pain and increasing function in patients with chronic (greater than three months' duration) lateral epicondylitis.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •males >18 yr and < 70 yr
- •BMI < 38
- •chronic lateral epicondylitis (symptomatic > 3 mo)
- •pain on provocation >/- 4 on 11 point scale
排除标准
- •patients on other pain medications
- •bilateral elbow pain
- •any humerus elbow or forearm fracture or surgery
- •signs of injury other than lateral epicondylitis
- •any concomitant disease or pain of the upper extremity
- •orthostatic hypotension
- •patients taking MAO inhibitors, phosphodiesterase inhibitors, adrenergic agents
- •pregnant or nursing women
结局指标
主要结局
pain-free grip strength
次要结局
- pain at rest
- pain on provocation
- function