Phase III "In-Life" Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, and Matching Placebo Gel in the Treatment and Prevention of Raynaud's Phenomenon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 24
- 主要终点
- Reduction in Raynaud's Condition Score
研究概览
简要总结
The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.
详细描述
The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •Outpatients, 18 years to 70 years.
- •Patients with a clinical diagnosis of Raynaud's phenomenon.
- •Patients who are willing to discontinue current vasodilator therapies.
- •Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
- •Negative pregnancy test in fertile women.
- •Patients who are able to give written informed consent and comply with all study requirements.
排除标准
- •Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
- •Patients who concurrently use any medication or device which might interfere with the study medication.
- •Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
- •Patients with a history of headaches.
- •Patients who have a history of an unstable medical problem.
- •Patients with cognitive or language difficulties.
- •Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
- •Patients who participated in a study of any investigational drug within four weeks prior to Visit
- •Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
- •Patients who have had major surgery within six months of Visit
- •Patients with interfering skin conditions.
- •Pregnant or nursing women.
结局指标
主要结局
Reduction in Raynaud's Condition Score
次要结局
- Frequency and Severity of adverse events