Self Selection Trial of Naproxen Sodium

Study Overview
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Brief Summary
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A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Official Title
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A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic

Conditions
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Pain

Intervention / Treatment
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* Drug: Naproxen sodium ER (BAYH6689)
* Drug: Advil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 12 years of age Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month 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 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 Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, 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 who have a positive urine pregnancy test or who are 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen Sodium ER (BAYH6689) or Advil IR<br>Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages. | Drug: Naproxen sodium ER (BAYH6689)<br>* Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain<br>Drug: Advil<br>* Commercially available Advil; oral caplet upon incidence of pain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B). | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours |  | Within 24 hours of their selection decision taken up to 14 days | 
| The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours | In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score </= 60 at visit 1. | Up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self Selection Tria