Self Selection Trial of Naproxen Sodium

Overview

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.

Full Title of Study: “A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2011

Interventions

  • Drug: Naproxen sodium ER (BAYH6689)
    • Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain
  • Drug: Advil
    • Commercially available Advil; oral caplet upon incidence of pain

Arms, Groups and Cohorts

  • Experimental: Naproxen Sodium ER (BAYH6689) or Advil IR
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
    • Time Frame: 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 Measures

  • 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.