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Completed

NCT Number: NCT01383486

Self Selection Trial of Naproxen Sodium

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen sodium ER (BAYH6689)

Drug

Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain

Advil

Drug

Commercially available Advil; oral caplet upon incidence of pain

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: KEIFER SST

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 28, 2011
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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