A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,117
- 试验地点
- 38
- 主要终点
- Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
研究概览
简要总结
An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following "stop use and ask a doctor if" and "ask a doctor before use" statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.
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 —（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
men
干预措施: tamsulosin hydrochloride (Drug)
结局指标
主要结局
Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1
时间窗: 12 weeks
Percentage of men who reported a condition listed under the "Stop use and ask a doctor if" section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval.
次要结局
- Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks(Week 12)
- Percentage of Men Who Report Condition Listed Under "Stop Use and Ask a Doctor if" Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks(Week 24)
- Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1(Week 12 and Week 24)
- Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1(24 weeks)
- Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1(Week 12 and Week 24)
- Percentage of Men Who Report a Condition Listed Under the "Stop Use and Ask a Doctor if" Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1(12 weeks)
- Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1(24 weeks)
- Percentage of Men Who Report at Baseline a Symptom or Condition Under the "Ask A Doctor Before Use" Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition(24 weeks)