Self Selection Trial of Naproxen Sodium

Bayer253 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

253

Conditions

Pain

Interventions

Naproxen sodium ER (BAYH6689)DRUG

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

AdvilDRUG

Commercially available Advil; oral caplet upon incidence of pain

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (10)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Yorba Linda, California, United States

Unnamed facility

Pembroke Pines, Florida, United States

Unnamed facility

Griffin, Georgia, United States

Outcomes

Primary Outcomes

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).

Time frame: up to 14 days

Secondary Outcomes

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

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.

Time frame: Up to 14 days

Data from ClinicalTrials.gov

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