Post Authorization Safety Study Assessing the Effectiveness of Risk Minimization Measures Related to Depakine® (Sodium Valproate) in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 455
- 试验地点
- 1
- 主要终点
- Percentage of healthcare professionals who received and read the educational materials
研究概览
简要总结
A cross-sectional, national, multicenter, survey-based study to assess the effectiveness of Risk Minimization Measures related to Depakine® (sodium valproate) in Saudi Arabia. The end of study is defined as the end of the data collection period. No intervention will be administered, and no study related visits are required.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare professionals working only in Saudi Arabia AND
- •Prescribers of Depakine® (sodium valiporate) at least once in the six months leading up to survey completion OR
- •Obstetricians/Gynecologists who consulted at least one women of childbearing potential treated with Depakine® (sodium valproate) in the six months leading up to survey completion OR
- •Pharmacists who have dispensed Depakine® (sodium valproate) in the six months leading up to survey completion
排除标准
- •Healthcare professionals who may have conflicts of interest with the survey (i.e. employed by regulatory bodies or pharmaceutical companies)
- •Healthcare professionals (or with a relative) involved in valproate-related lawsuits or associations for victims of valproate syndrome
- •Healthcare professionals who are not prescribing Depakine® (sodium valproate), except for obstetricians/gynecologists (who do not prescribe Depakine® [sodium valproate])
- •Healthcare professionals having started to prescribe or dispense Depakine® (sodium valproate) earlier than six months before survey completion
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Sodium valporate
Participants are healthcare professionals completing a survey regarding women of childbearing potential using sodium valporate, prescribe or dispense the treatment
干预措施: Sodium valporate (Drug)
结局指标
主要结局
Percentage of healthcare professionals who received and read the educational materials
时间窗: 7 months
Healthcare professionals' knowledge score
时间窗: 7 months
Knowledge score is calculated as the proportion of correct responses among all questions related to knowledge
Healthcare professionals' behavior score
时间窗: 7 months
Behavior score is calculated as the proportion of correct responses among all questions related to behavior
次要结局
未报告次要终点