A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
研究概览
简要总结
The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.
详细描述
Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers
- •a history of at least two Raynaud's events during a typical winter day
- •must be willing to apply creams to fingers
- •must be willing to undergo cold temperature exposure
- •must be willing and able to stop certain medications
- •must be willing to use effective contraception, if applicable
排除标准
- •had a Raynaud's attack that required hospital or clinic intervention
- •has allergies to nitroglycerin or topical medication ingredients
- •has a history of migraine or chronic pain
- •has an unstable medical problem that could interfere with the study
- •had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months
- •used any investigational drug in the past 4 weeks
- •has significantly abnormal laboratory tests
- •had certain major surgeries in the past 6 months
- •has skin lesions on certain parts of the fingers
- •women who are pregnant or nursing
研究组 & 干预措施
Vascana
干预措施: 0.9% nitroglycerin in TAM cream (Drug)
Vehicle
干预措施: vehicle cream (Drug)
结局指标
主要结局
Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)
时间窗: 2 weeks
次要结局
- Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)(2 weeks)
- Changes from baseline in duration of Raynaud's attacks(2 weeks)
- Changes from baseline in number of Raynaud's attacks(2 weeks)
- Changes from baseline in the Raynaud's Condition Score(2 weeks)
- Changes in the maximum reduction in skin temperature(2 weeks)
- Changes from baseline in overall disease severity measures(2 weeks)
- Changes in the time to return to baseline skin temperature(2 weeks)