Naproxen Sodium Extended-Release Actual Use Study

Study Overview
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Brief Summary
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The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Detailed Description
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Issues on adverse event data are addressed in the Adverse Event section. The following acronyms and abbreviations were used in the results section. - General Educational Development (GED)

Official Title
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An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

Conditions
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Pain

Intervention / Treatment
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* Drug: Naproxen Sodium ER (BAYH6689)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self report use of Over The Counter (OTC) analgesics Able to read and understand English Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent) Purchase the investigational product Exclusion Criteria: Have participated in a study involving OTC analgesics in the last 12 months They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin 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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen Sodium ER (BAYH6689)<br>subjects take one tablet Naproxen Sodium ER (extended release) every 24 hours while symptoms last for no more than 10 consecutive days for pain and no more than 3 consecutive days for fever | Drug: Naproxen Sodium ER (BAYH6689)<br>* Consumer use of Extended Release Naproxen Sodium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use Days With One or More Misuse Occasions | Misuse occasion: any reported use of 2 or more tablets within a 22 hour period (included use of 2 tablets in 1 dose or the use of 1 tablet at one time and 1+ tablets at a later time within the same 22 hour period). Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in 1 use-day. If a subject reported product consumption on 3 different days this resulted in 3 use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosing Occasions With One and More Than One Tablet Taken | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. | 1 month | 
| Use Days With and Without Next Dose Less Than 22 Hours Later | Use-days were calculated based on days in which there was subject-reported product consumption, meaning that if a tablet was consumed on a day this resulted in one use-day. If a subject reported product consumption on three different days this resulted in three use-days. The cumulative expression of use-days is the total number of use-days reported by all subjects with follow up data. | 1 month | 
| Number of Subjects With and Without More Than One Tablet Taken Per Dose |  | 1 month | 
| Number of Subjects With and Without Next Dose Less Than 22 Hours Later | This Outcome is a measure of subjects while Outcome Measure 3 provides the outcome as a measure of cumulative number of use-days for all subjects involved. | 1 month | 
| Number of Subjects With and Without More Than 660 mg at Least Once | This measure refers to number of subjects that exceeded 660 mg of naproxen sodium per day at least once during the reporting period. The maximum dose (660 mg) may have been exceeded with one dose (if a subject consumed two tablets in one dosing occasion) or may have been exceeded throughout the course of a use-day (if a subject took one tablet in one dosing occasion and then later in the same day took one or more tablets in another dosing occasion). | 1 month | 
| Average Daily Dose |  | 1 month | 
| Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days | This measure is reporting how many subjects exceeded the label limit for consecutive days of study drug dosing | 1 month | 
| Number of Total Dosing Occasions Per Subject | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. | 1 month | 
| Number of Dosing Occasions Per Subject That Exceeded 660 mg | Dosing occasion means a single occasion in which a subject reported consuming the study drug. Multiple dosing occasions were possible throughout one use-day. For example, if a subject took one tablet at 6 am this would result in one dosing occasion. If the same subject took one tablet later that same day at 8 pm this would result in a second dosing occasion. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-prescription