Actual Use Trial of Naproxen Sodium

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Naproxen Sodium ER (BAYH6689)

• Registration Number: NCT01427803
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-31
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2013-02-05
• Results First Submitted QC: 2013-04-09
• Results First Posted: 2013-05-20
• Status Verified: 2014-04
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 778

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Naproxen Sodium ER (BAYH6689)	-

Primary Outcome Measures

Name	Time	Method
Estimated Percentage of Misuse for Non-Therapeutic Reasons	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.

Secondary Outcome Measures

Name	Time	Method
Non-therapeutic Reasons for Misuse	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.
Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course	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."
Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days	28 days	Percentage of participants took \>/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day	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.
Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken	28 days	Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
Percentage of Dosing Occasions Where More Than One Tablet Was Taken	28 days	Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose	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.
Percentage of Dosing Occasions 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. 22 hrs was chosen to allow for some imprecision in subjects' recollection