Self Selection Trial of Naproxen Sodium

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Naproxen Sodium ER (BAYH6689) or Advil IR	Naproxen sodium ER (BAYH6689)	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.
Naproxen Sodium ER (BAYH6689) or Advil IR	Advil	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.

Primary Outcome Measures

Name	Time	Method
The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours	up to 14 days	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).

Secondary Outcome Measures

Name	Time	Method
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	Up to 14 days	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.