Actual Use Trial of Naproxen Sodium
Public ClinicalTrials.gov record NCT01427803. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01427803
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 778 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Dec 2011 (Actual)
- Completion
- Dec 2011 (Actual)
- Last update posted
- Oct 15, 2015
2011
United States locations
- U.S. sites
- 34
- U.S. states
- 11
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hoover | Alabama | 35226 | — |
| Not listed | McCalla | Alabama | 35111-3406 | — |
| Not listed | Pinson | Alabama | 35126 | — |
| Not listed | Mesa | Arizona | 85202 | — |
| Not listed | Anaheim | California | 92801 | — |
| Not listed | Oceanside | California | 92054 | — |
| Not listed | Yorba Linda | California | 92886 | — |
| Not listed | Overland Park | Kansas | 66209 | — |
| Not listed | Baltimore | Maryland | 21228 | — |
| Not listed | Andover | Minnesota | 55304 | — |
| Not listed | Elk River | Minnesota | 55330 | — |
| Not listed | Fridley | Minnesota | 55432 | — |
| Not listed | Northfield | Minnesota | 55057-2434 | — |
| Not listed | Rosemount | Minnesota | 55068 | — |
| Not listed | Roseville | Minnesota | 55113 | — |
| Not listed | Kansas City | Missouri | 64111 | — |
| Not listed | Saint Joseph | Missouri | 64504 | — |
| Not listed | Savannah | Missouri | 64485 | — |
| Not listed | Albuquerque | New Mexico | 87104 | — |
| Not listed | Albuquerque | New Mexico | 87107 | — |
| Not listed | Taos | New Mexico | 87571 | — |
| Not listed | Bountiful | Utah | 84010 | — |
| Not listed | Hurricane | Utah | 84737 | — |
| Not listed | Layton | Utah | 84041 | — |
| Not listed | Ogden | Utah | 84401 | — |
| Not listed | Salt Lake City | Utah | 84102 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | Syracuse | Utah | 84075 | — |
| Not listed | West Jordan | Utah | 84088 | — |
| Not listed | Montpelier | Virginia | 23192 | — |
| Not listed | Richmond | Virginia | 23221 | — |
| Not listed | Bellevue | Washington | 98007 | — |
| Not listed | Kenmore | Washington | 98028 | — |
| Not listed | Snohomish | Washington | 98290 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01427803, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 15, 2015 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01427803 live on ClinicalTrials.gov.