Actual Use Trial of Naproxen Sodium (Kiefer AUT)
2015年9月24日 更新者：Bayer
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
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.
研究概览
研究类型
介入性
注册 (实际的)
778
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Alabama
-
Hoover、Alabama、美国、35226
-
McCalla、Alabama、美国、35111-3406
-
Pinson、Alabama、美国、35126
-
-
Arizona
-
Mesa、Arizona、美国、85202
-
-
California
-
Anaheim、California、美国、92801
-
Oceanside、California、美国、92054
-
Yorba Linda、California、美国、92886
-
-
Kansas
-
Overland Park、Kansas、美国、66209
-
-
Maryland
-
Baltimore、Maryland、美国、21228
-
-
Minnesota
-
Andover、Minnesota、美国、55304
-
Elk River、Minnesota、美国、55330
-
Fridley、Minnesota、美国、55432
-
Northfield、Minnesota、美国、55057-2434
-
Rosemount、Minnesota、美国、55068
-
Roseville、Minnesota、美国、55113
-
-
Missouri
-
Kansas City、Missouri、美国、64111
-
Savannah、Missouri、美国、64485
-
St. Joseph、Missouri、美国、64504
-
-
New Mexico
-
Albuquerque、New Mexico、美国、87104
-
Albuquerque、New Mexico、美国、87107
-
Taos、New Mexico、美国、87571
-
-
Utah
-
Bountiful、Utah、美国、84010
-
Hurricane、Utah、美国、84737
-
Layton、Utah、美国、84041
-
Ogden、Utah、美国、84401
-
Salt Lake City、Utah、美国、84121
-
Salt Lake City、Utah、美国、84102
-
Syracuse、Utah、美国、84075
-
West Jordan、Utah、美国、84088
-
-
Virginia
-
Montpelier、Virginia、美国、23192
-
Richmond、Virginia、美国、23221
-
-
Washington
-
Bellevue、Washington、美国、98007
-
Kenmore、Washington、美国、98028
-
Snohomish、Washington、美国、98290
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 及以上 (孩子、成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：手臂 1
|
BAYH6689; oral tablet used as needed upon incidence of pain
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Estimated Percentage of Misuse for Non-Therapeutic Reasons
大体时间：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.
|
28 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Non-therapeutic Reasons for Misuse
大体时间：28 days
|
Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.
|
28 days
|
|
Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
大体时间：28 days
|
This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse.
The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day".
A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."
|
28 days
|
|
Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
大体时间：28 days
|
Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
|
28 days
|
|
Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
大体时间：28 days
|
Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.
|
28 days
|
|
Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
大体时间：28 days
|
Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
|
28 days
|
|
Percentage of Dosing Occasions Where More Than One Tablet Was Taken
大体时间：28 days
|
Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
|
28 days
|
|
Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
大体时间：28 days
|
Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions.
22 hrs was chosen to allow for some imprecision in subjects' recollection.
|
28 days
|
|
Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
大体时间：28 days
|
Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose.
22 hrs was chosen to allow for some imprecision in subjects' recollection
|
28 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年9月1日
初级完成 (实际的)
2011年12月1日
研究完成 (实际的)
2011年12月1日
研究注册日期
首次提交
2011年8月31日
首先提交符合 QC 标准的
2011年9月1日
首次发布 (估计)
2011年9月2日
研究记录更新
最后更新发布 (估计)
2015年10月15日
上次提交的符合 QC 标准的更新
2015年9月24日
最后验证
2014年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.