NCT00004786已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Iloprost for Raynaud's Phenomenon Secondary to Systemic Sclerosis
National Center for Research Resources (NCRR)0 个研究点目标入组 200 人开始时间: 1995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
研究概览
简要总结
OBJECTIVES:
I. Evaluate the safety and efficacy of oral iloprost, a prostacyclin analog, in patients with Raynaud's phenomenon secondary to systemic sclerosis.
详细描述
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution and digital cutaneous ulcers.
Patients receive oral iloprost or placebo twice daily for 6 weeks. Thrombolytic drugs, oral anticoagulants, and heparin are prohibited on study. Concurrent therapy with angiotensin-converting enzyme inhibitors for Raynaud's is prohibited; calcium channel blockers for severe digital ischemia are allowed as needed.
Patients are followed at 2 and 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Raynaud's phenomenon secondary to systemic sclerosis (SS) SS meets American College of Rheumatology diagnostic criteria
- •At least 6 Raynaud's attacks per week
- •-Prior/Concurrent Therapy--
- •No prior participation in oral iloprost study
- •At least 4 weeks since participation in other investigational drug studies
- •At least 2 months since prostanoid therapy
- •At least 12 months since sympathectomy of upper limb
- •Ongoing therapy for systemic sclerosis may continue on study Raynaud's therapy discontinued at entry
- •-Patient Characteristics--
- •Hematopoietic: No platelet disorder
- •Hepatic: No bleeding diathesis
- •Renal: Creatinine clearance (estimated) at least 30 mL/min
- •Cardiovascular:
- •No unstable angina pectoris
- •None of the following within 3 months:
- •Transient ischemic attack
- •Myocardial infarction
- •No active cancer or other uncontrolled disease
- •No current history of alcohol or drug abuse
- •No mental disorder precluding compliance
- •No pregnant or nursing women
- •Negative pregnancy test required of fertile women
- •Adequate contraception required of fertile women
排除标准
- 未提供
研究者
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