Self Selection Trial of Naproxen Sodium (KEIFER SST)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Naproxen sodium ER (BAYH6689); Drug: Advil

• Study Type: Interventional
• Enrollment (Actual): 253
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
    • Yorba Linda, California, United States, 92886
  • Florida
    • Pembroke Pines, Florida, United States, 33026
  • Georgia
    • Griffin, Georgia, United States, 30224
  • Minnesota
    • Andover, Minnesota, United States, 55304
    • Roseville, Minnesota, United States, 55113
  • Utah
    • Bountiful, Utah, United States, 84010
    • West Jordan, Utah, United States, 84088
  • Washington
    • Bellevue, Washington, United States, 98007
    • Seattle, Washington, United States, 98122

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 27, 2011
• First Submitted That Met QC Criteria: June 27, 2011
• First Posted (Estimate): June 28, 2011

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Self Selection Tria
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 15833; 2014-005305-20 (EudraCT Number)