NCT00378521已完成2 期
Phase II Dose Response Study of a Topical Gel Formulation of Nitroglycerin, MQX-503, in the Treatment of Raynaud's Phenomenon
MediQuest Therapeutics2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2006年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Measure the time required for blood flow to return to baseline after cold exposure
研究概览
简要总结
The Purpose of this study is to determine the response to two different strengths of a topical gel containing nitroglycerin in patients with Raynaud's disease.
详细描述
The Purpose of this clinical study is to determine, in a controlled fashion, the response to two dosage strengths of a topical gel formulation of Nitroglycerin, MQX-503, in the determination of changes in finger blood flow and skin temperature in the fingers of patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma. The dosage strength response in the treatment of the symptoms (pain, tingling, numbness) will also be monitored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients, 18 to 75 years
- •Clinical Diagnosis of Raynaud's, or observed event by study physician, or symptoms with reduced blood flow as meausred using laser doppler equipment
- •Agree to have test gels applied to finger
- •Discontinue current vasodialator therapeis for Raynaud's treatment
- •Four weeks from last clinical trial participation
- •Agree not to use any other investigational medications or therapies to treat Raynaud's and its symptoms while participating in this study including other dosages or forms of nitroglycerin, isosorbide dinitrate, fenoldopam mesylate, milrinone lactate, nifedipine, diltiazem, felodipine, nimodipine, nisoldipine, and verapamil
- •Negative pregnancy test for women prior to study start and agree to use effective contraception throughout
- •Must be able to give written informed consent and comply with all study requirements
排除标准
- •Concurrent use of any nitrate medication or medications known to interact with Nitroglycerin such as sildenafil, and other treatments for erectile dysfunction
- •Patients who have a known allergy to Nitroglycerin or common topical gel ingredients
- •Patients with a history of migraine, cluster or vascular headaches, or those who suffer from chronic pain
- •Patients with a history of an unstable medical problem or any current condition that would interfere in participation in the study
- •Patients unable to complete pain assessment instructions
- •Patients who in the last three months have had a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension
- •Patients who have participated in another investigational drug study within four weeks of the first study treatment
- •Patients with out of range laboratory screening values
- •Patients who have had major abdominal, thoracic or vascular surgery within six months of the first study treatment
- •Patients with open lesions or skin conditions where gel is to be applied
- •Pregnant or nursing women
- •Women who will not agree to comply with contraceptive requirements
- •Patients with a history of poor compliance, poor cooperation or unreliability
结局指标
主要结局
Measure the time required for blood flow to return to baseline after cold exposure
次要结局
- Measure the time required for skin temperature to return to baseline after cold exposure
- Prevention or reduction of symptoms following cold exposure.
研究者
研究点 (2)
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