An Open-label, Multi-centre, Observational, Post-marketing Surveillance to Monitor the Safety of REQUIP(Ropinirole) Administered in Korean Restless Leg Syndrome Patients According to the Prescribing Information
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 755
- 主要终点
- Number of Participants With Any Adverse Event
研究概览
简要总结
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
详细描述
This study is a post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS(restless leg syndrome) and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to identify prognostic factors that have an effect on the AEs and to assess effectiveness of ropinirole in real clinical practices after marketing. The subjects are patients prescribed for ropinirole by the investigators at the sites based on prescription information in normal clinical practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with RLS by the investigator
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol
- •To be contactable over the phone
- •To follow the administration regimen.
- •A male or female aged 18 years and more at the time of the first prescription.
- •Subjects with no experience of RLS treatment using ropinirole
排除标准
- •Considering the nature of this non-interventional PMS study, there is no strict exclusion criteria set up. GSK Korea encourage the doctors participating this study to enrol the subjects prescribed with Ropinirole following the locally approved Prescribing Information (Appendix ) The following criteria should be checked at the time of study entry.
- •Subjects with hypersensitivity to ropinirole and any excipients
- •Female who is during the period of the pregnancy or who are lactating
研究组 & 干预措施
Subjects eligible for REQUIP prescription
Male and female subjects who were considered appropriate to be prescribed REQUIP according to the prescribing information will be included in this study.
干预措施: Ropinirole (Drug)
结局指标
主要结局
Number of Participants With Any Adverse Event
时间窗: one month
An adverse event is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
次要结局
- Number of Participants With Any Serious Adverse Event(one month)
- Number of Participants With the Indicated Unexpected Adverse Events(one month)