跳至主要内容
临床试验/NCT00225862
NCT00225862已完成3 期

A 12-week, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of Intermittent Dosing of Ropinirole in Patients With Restless Legs Syndrome (RLS)

GlaxoSmithKline38 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2005年1月最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
140
试验地点
38
主要终点
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.

研究概览

简要总结

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.

时间窗: 12 Weeks

次要结局

  • Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.(12 Weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (38)

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