NCT01726270已完成2 期
A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 689
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Appropriately Followed the Label Instructions
研究概览
简要总结
Multicenter trial conducted in Pharmacy retail centers
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Male
- 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
tamsulosin hydrochloride
Experimental
patients will take drug for 8 weeks in this exploratory study
干预措施: tamsulosin (Drug)
结局指标
主要结局
Percentage of Participants Who Appropriately Followed the Label Instructions
时间窗: 8 weeks
Includes subjects who reported: 1. No improvement in urinary symptoms and stopped taking product, 2. Reported worsening of urinary symptoms and stopped taking the product, 3. Reported a new urinary symptom and stopped taking the product, 4. Reported no "Stop Use" condition and never took more than 1 capsule on any given day, 5. Reported a "Stop Use" condition and contacted a provider.
次要结局
- Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day(8 weeks)
- Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase(8 weeks)
- Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population(8 weeks)
- Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population(8 weeks)
- Percentage of Participants Who Took no More Than One Capsule Per Day(8 weeks)
研究者
研究点 (1)
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