NCT01427803已完成3 期
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 778
- 主要终点
- Estimated Percentage of Misuse for Non-Therapeutic Reasons
研究概览
简要总结
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 12 years of age
- •Report taking OTC analgesics for pain on at least 5 days in the last month
- •Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
- •Able to read and understand English
- •Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
- •Provide contact information
- •Purchase the investigational product
排除标准
- •Have participated in a trial involving OTC analgesics in the last 6 months
- •They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
- •Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)
- •Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
- •(Female subjects) are pregnant or breastfeeding
研究组 & 干预措施
Arm 1
Experimental
干预措施: Naproxen Sodium ER (BAYH6689) (Drug)
结局指标
主要结局
Estimated Percentage of Misuse for Non-Therapeutic Reasons
时间窗: 28 days
The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.
次要结局
- Non-therapeutic Reasons for Misuse(28 days)
- Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course(28 days)
- Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days(28 days)
- Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day(28 days)
- Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken(28 days)
- Percentage of Dosing Occasions Where More Than One Tablet Was Taken(28 days)
- Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose(28 days)
- Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose(28 days)
研究者
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