A Study of a Topical Formulation of Nitroglycerin, MQX-503, and Matching Vehicle in the Treatment and Prevention of Raynaud's Phenomenon
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 200
- 试验地点
- 17
- 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 (MQX0503) 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 a topical formulation of 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 (RP) and with moderate to severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients ages 15 -
- •Patients with a diagnosis of Raynaud's phenomenon.
- •Patients who agree to apply study medication to their fingers.
- •Patients who are willing to stop current topical vasodilator therapies.
- •Patients who agree not to start or change dosage of current oral vasodilator therapies.
- •Patients who agree not to use any nitrate therapy while participating in this study.
- •Negative pregnancy test in fertile women and agreement to use effective contraception throughout the study.
排除标准
- •Patients who currently use nitrate medication or medications known to interact with nitroglycerin.
- •Patients who have an allergy to nitroglycerin or common topical gel ingredients.
- •Patients with a history of severe headaches.
- •Patients with an unstable medical problem.
- •Patients with cognitive or language difficulties that would impair their ability to complete assessment of pain instruments.
- •Patients who have had a recent heart attack or other uncontrolled heart condition.
- •Patients who have participated in an investigational drug study within four weeks of visit one.
- •Patients who have clinically significant abnormal lab values.
- •Patients who have had recent major abdominal, thoracic or vascular surgery.
- •Patients with interfering skin conditions.
- •Pregnant or nursing women or women unwilling to comply with contraceptive requirements.
研究组 & 干预措施
2
Placebo - Topical AmphiMatrix
干预措施: Topical AmphiMatrix (Drug)
1
Topical AmphiMatrix with Nitroglycerin
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Reduction in Raynaud's Condition Score
时间窗: three months
次要结局
- Frequency and severity of adverse events.(three months)