A Multi-Center, Open-Label, All-Comers, Single Group Observational Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC )Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 1,500
- 试验地点
- 29
- 主要终点
- The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
研究概览
简要总结
This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental 1
干预措施: Rabeprazole sodium (Drug)
结局指标
主要结局
The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
时间窗: screening visit (Day 0 )
The percentage of subjects who follow key directions for use (1 tablet per day, 14-day course of treatment, and no more than one course of treatment every 4 months)
时间窗: 14 day treatment period; up to 4 months
The percentage of subjects who make appropriate ongoing decisions about suitability for treatment (including consulting a physician and appropriately modifying or discontinuing use based on label directions)
时间窗: 14 day treatment period; up to 4 months
The percentage of subjects who experience serious / non-serious adverse events
时间窗: : 14 day treatment period; up to 4 months
次要结局
未报告次要终点