NCT00266669已完成3 期
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
MediQuest Therapeutics38 个研究点 分布在 2 个国家目标入组 200 人开始时间: 2005年12月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 38
- 主要终点
- Improvements in Raynaud's Assessment Score comparing active to placebo
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary Raynaud's phenomenon or patients 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
- Single Group
- 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
- 否
入选标准
- •Clinical diagnosis of Raynaud's phenomenon
- •2 or more Raynaud's events on a typical winter day
- •Agree to discontinue current treatments for Raynaud's
- •Negative pregnancy test and agree to use effective contraception during study
排除标准
- •Current use of nitrate medications or medications known to interact with nitroglycerin
- •Patients who currently use medications, like calcium channel blockers, that might interfere with study medication
- •Patients with a known allergy to nitroglycerin or common topical ingredients
- •Patients with a history of migraine headaches
- •Patients with a history of unstable medical problems
- •Patients with cognitive or language difficulties that would impair completion of assessment instruments
- •Patients with lab screening values more than 20% outside normal range
- •Patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening
- •Pregnant or nursing women
- •Women of child-bearing potential who are unwilling to comply with the contraceptive requirements
结局指标
主要结局
Improvements in Raynaud's Assessment Score comparing active to placebo
Reduction of number of Raynaud's events
Decrease in duration of Raynaud's events
Decrease in symptoms associated with Raynaud's
Assess safety: frequency and severity of adverse events associated with the study drug
次要结局
- Improvement in patient's health using physician's Global Assessment and patient's Heath Assessment Questions
- Reduction in emergence of digital ulcers for patients with scleroderma
研究者
研究点 (38)
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