Phase 3
Completed N=253
Self Selection Trial of Naproxen Sodium
Source: ClinicalTrials.gov NCT01383486 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours — 72.0 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours |
72.0 | — |
| SECONDARY 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 |
71.5 | — |
| SECONDARY The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours |
64.5 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01383486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.