Phase 3
Completed N=778
Actual Use Trial of Naproxen Sodium
Source: ClinicalTrials.gov NCT01427803 ↗Enrolled (actual)
778
Serious AEs
0.8%
Results posted
May 2013
Primary outcomePrimary: Estimated Percentage of Misuse for Non-Therapeutic Reasons — 6.5 Percentage of Participants
Summary
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estimated Percentage of Misuse for Non-Therapeutic Reasons |
6.5 | — |
| SECONDARY Non-therapeutic Reasons for Misuse |
52 | — |
| SECONDARY Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course |
5 | — |
| SECONDARY Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days |
14.9 | — |
| SECONDARY Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day |
4.8 | — |
| SECONDARY Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken |
19.7 | — |
| SECONDARY Percentage of Dosing Occasions Where More Than One Tablet Was Taken |
5.4 | — |
| SECONDARY Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose |
72.5 | — |
| SECONDARY Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose |
27.8 | — |
Eligibility Criteria
Inclusion Criteria
- At least 12 years of age
- Report taking OTC analgesics for pain on at least 5 days in the last month
- Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
- 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
- Purchase the investigational product
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 NSAIDs (i.e., naproxen, ibuprofen, 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) are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT01427803). 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.