Phase III Laboratory Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Differntial time for blood flow to return to baseline following cold exposure.
研究概览
简要总结
The purpose of this study is to determine, in comparison to a placebo control, the response to two dosage strengths of a topical gel formulation of nitroglycerin, MQX-303, in the determination of finger blood flow and skin temperature in the fingers of patients with moderate to severe Raynaud's phenomenon, follwoing exposure to cold temperatures.
Blood flow is determined by scanning laser Doppler equipment and skin temperature is measured using attached thermistor probes. Following baseline measurements, the study gel is applied, the hand is placed in a cold chamber, and then blood flow and skin temperature are monitored for the next two hours.
Each patient will receive multiple doses on different days so that each can serve as his/her own control in interpreting the response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of Raynaud's phenomenon
- •outpoatients
- •agree to apply gel as per protocol
- •willing to discontinue current vasodilator therapy
- •agree to stop other investigational medication for Raynaud's
- •negative pregnancy test is fertile females
- •able to give written informed consent and comply with study requirements
排除标准
- •current use of ay nitrate medication or medications that interact with nitroglycerin
- •patients with a known allergy to nitroglycerin or topical gel ingredients
- •patients with a history of migraine headaches
- •patients with unstable medical problems
- •patients with cognitive or language difficulties
- •patients with screening lab values more than 20% outside of normal
- •patients with open lesions at site of application
- •women of child-bearing potential who are unwilling to comply with contraceptive requirements.
结局指标
主要结局
Differntial time for blood flow to return to baseline following cold exposure.
次要结局
- Differential time for skin temperature to return to baseline following cold exposure.
- Quantitative reduction or prevention in symptoms following cold exposure.