A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- Changes in the IRLS score between the two treatment arms will be compared
研究概览
简要总结
The primary objective for the 12-week Titration-/Maintenance Period is:
To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.
详细描述
A randomised, double-blind, placebo-controlled, parallel-group, multicenter study to demonstrate improvement of symptoms of RLS in subjects with moderate to severe idiopathic RLS with daytime symptoms who take oxycodone/naloxone prolonged release (OXN PR) compared to subjects taking placebo (PLA).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Moderate to severe idiopathic RLS with daytime symptoms
排除标准
- •Females who are pregnant or lactating.
- •Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
- •Subjects with evidence of impaired liver/kidney function upon entry into the study
研究组 & 干预措施
OXN PR
Different daily doses; intake every 12 hours
干预措施: Oxycodone naloxone prolonged release tablets (OXN PR) (Drug)
PLA
Different daily doses; intake every 12 hours
干预措施: Oxycodone naloxone prolonged release tablets (OXN PR) (Drug)
PLA
Different daily doses; intake every 12 hours
干预措施: Placebo (PLA) (Other)
结局指标
主要结局
Changes in the IRLS score between the two treatment arms will be compared
时间窗: 12 weeks and a 6 month extension
The primary objective for the 12-week Titration-/Maintenance Period is: IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period.
次要结局
未报告次要终点