Phase 3
Completed N=497
Naproxen Sodium Extended-Release Actual Use Study
Source: ClinicalTrials.gov NCT00751400 ↗Enrolled (actual)
497
Serious AEs
0.6%
Results posted
May 2011
Primary outcomePrimary: Use Days With One or More Misuse Occasions — 2112; 294 days
Summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Use Days With One or More Misuse Occasions |
2112; 294 | — |
| SECONDARY Dosing Occasions With One and More Than One Tablet Taken |
2500; 66 | — |
| SECONDARY Use Days With and Without Next Dose Less Than 22 Hours Later |
2175; 231 | — |
| SECONDARY Number of Subjects With and Without More Than One Tablet Taken Per Dose |
440; 27 | — |
| SECONDARY Number of Subjects With and Without Next Dose Less Than 22 Hours Later |
359; 108 | — |
| SECONDARY Number of Subjects With and Without More Than 660 mg at Least Once |
344; 123 | — |
| SECONDARY Average Daily Dose |
722 | — |
| SECONDARY Number of Subjects That Have Taken Study Drug on More Than 10 Consecutive Days and Not on More Than 10 Consecutive Days |
376; 109 | — |
| SECONDARY Number of Total Dosing Occasions Per Subject |
5.5 | — |
| SECONDARY Number of Dosing Occasions Per Subject That Exceeded 660 mg |
0.6 | — |
Eligibility Criteria
Inclusion Criteria
- Self report use of Over The Counter (OTC) analgesics
- Able to read and understand English
- Provide written informed consent (subjects 12- 17 years of age provide written as sent and/ or parent or legal guardian provide written consent)
- Purchase the investigational product
Exclusion Criteria
- Have participated in a study involving OTC analgesics in the last 12 months
- They or someone else in the household work for a market research company, an advertising agency, a public relations firm, pharmaceutical company, as a healthcare professional, or as part of a health care practice
- Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs) (i.e., Naproxen, Ibuprofen, etc) or Aspirin
- 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 (NCT00751400). 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.