NCT01887613已完成不适用
Specified Drug Use-Results Survey of Regnite
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,597
- 主要终点
- Safety such as occurrence of adverse drug reactions and lab-tests
研究概览
简要总结
This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.
详细描述
Sleeping condition and severity of restless legs syndrome (RLS) were recorded at the start and during the treatment. The treatment period is scheduled to last 52 weeks in principle. For patients completing or discontinuing the use of Regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate to severe idiopathic restless legs syndrome
排除标准
- •Patients with a history of hypersensitivity to any ingredients in Regnite or gabapentin
- •Patients with severely impaired renal function (creatinine clearance of less than 30 mL/min)
研究组 & 干预措施
Regnite group
Patients who receive Regnite
干预措施: Regnite (Drug)
结局指标
主要结局
Safety such as occurrence of adverse drug reactions and lab-tests
时间窗: Up to 52 weeks
次要结局
- Clinical Global Impression(Baseline and at 52 weeks)
- Restless Leg Syndrome score(Baseline and at 52 weeks)
研究者
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