NCT00428883Unknown2 期
Rare Disease With Microvascular Involvement: High Dose Intravenous N-Acetylcysteine Versus Iloprost for Early, Rapidly Progressive Diffuse Systemic Sclerosis
Università Politecnica delle Marche9 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2007年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- The primary outcome is the reduction of skin thickness
研究概览
简要总结
- Systemic sclerosis (scleroderma; SSc) is a rare, disfiguring systemic disorder characterized by fibrosis of the skin and visceral organs that alters every aspect of an individual life
- Although some features of scleroderma phenotype are well established and represent the hallmarks of the disease, the primary cause is not fully delineated, though both endothelial cell damage, immunological abnormalities and excessive extracellular matrix production are well-documented
- Recently, excessive oxidative stress has been implicated in the pathogenesis of scleroderma
- N-acetylcysteine (NAC) exhibits direct and indirect antioxidant properties. Its free thiol group is capable of interacting with the electrophilic groups of ROS. This interaction with ROS leads to intermediate formation of NAC thiol, with NAC disulphide as a major end product. The net result is a decrease of the concentrations of OH-, H2O2, and HOCl. In addition, NAC exerts an indirect antioxidant effect related to its role as a glutathione (GSH) precursor. It serves as a central factor in protecting against internal toxic agents.
- In view of these considerations we expect that NAC can confer substantial benefit in patients with scleroderma reducing skin fibrosis in view of its antioxidant properties, and we have decided to conduct a double blind, multicenter trial to establish whether NAC could ameliorate skin fibrosis in scleroderma patients
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of early diffuse scleroderma
- •ability to give an informed consent
- •use of an acceptable method of birth control (if women in childbearing age). Pregnancy will be ruled out before study beginning.
排除标准
- •connective tissue diseases or other autoimmune diseases other than SSc;
- •history of intolerance to the study drugs;
- •severe cardiac failure (NYHA >=3 or left ventricular ejection fraction <40%), recent (<6 months) history of myocardial infarction; symptomatic ischemic myocardial disease, ventricular tachyarrhythmia, atrial fibrillation;
- •resting PaO2 <60mm/hg
- •creatinine clearance below 90ml/h
- •severe hepatic failure
- •bronchial asthma h. hemorrhagic diathesis i. pregnancy or lactation
结局指标
主要结局
The primary outcome is the reduction of skin thickness
Evaluated by the modified Rodnan skin score.
次要结局
- scleroderma disease activity assessed as established
- patient physical and emotional well-being (VAS, HAQ, SF36)
- laboratory evidence of skin fibroblast activation;
- the levels of Glutathione and of oxidized glutathione (GSSG).
研究者
研究点 (9)
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