DOUBLE BLIND STUDY WITH ORAL ILOPROST AND PLACEBO IN RAYNAUD'S PHENOMENON

口服伊洛前列素和安慰剂治疗雷诺现象的双盲研究

• 批准号: 6245684
• 负责人: THOMAS MEDSGER
• 金额: $ 1.76万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-03-18 至 1997-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6245684
• 关键词: Raynaud's disease; cardiovascular disorder chemotherapy; clinical research; clinical trial phase I; human subject; human therapy evaluation; iloprost; oral administration

Raynaud's phenomenon secondary to systemic sclerosis (scleroderma) is a debilitating condition. Iloprost (iloprost-beta-cyclodextrim-clathrate) is a prostacyclin (PGI2) analog shown to be effective in reducing the frequency & severity of Raynaud's phenomenon in scleroderma when given intravenously. This is a multicenter study to evaluate the effectiveness and safety of oral Iloprost 50 mcg b.i.d. for a total treatment period of 6 weeks. The patient-completed visulanalog scale Raynaud's condition score is the primary outcome variable.

继发性系统性硬化症(硬皮病)的雷诺现象是一种 使人虚弱的状况。伊洛前列素(伊洛前列素-β-环糊精-笼合物) 前列环素(PGI2)类似物是否被证明能有效降低 硬皮病中雷诺氏现象的频率和严重程度 静脉注射。这是一项评估有效性的多中心研究。 口服伊洛前列素50微克，每日2次，安全。对于总的治疗期 共6周。患者完成的视觉模拟评分雷诺氏病 得分是主要的结果变量。