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NCT01383486 · ClinicalTrials.gov registry record · Phase 3
Self Selection Trial of Naproxen Sodium
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 253
- Enrollment target
NCT01383486: Completed Phase 3 study, sponsored by Bayer.
NCT01383486 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 253 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01383486, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 253 participants
- Enrollment target
Study 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.
Primary Outcome
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 an
Interventions
- DRUG Naproxen sodium ER (BAYH6689)
- DRUG Advil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 253 participants |
| Start Date | 2011-07 |
| Est. Completion | 2011-08 |
| Phase | Phase 3 |
What the finished NCT01383486 record still lists
NCT01383486 is an interventional study that assigns participants to a tested intervention. The registered 253 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Naproxen sodium ER (BAYH6689) is the first listed.
NCT01383486 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01383486 about?
NCT01383486 is a clinical study titled "Self Selection Trial of Naproxen Sodium". 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.
What is the current status of trial NCT01383486?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 253 participants. The study started on 2011-07. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01383486?
The interventions under investigation include: Naproxen sodium ER (BAYH6689) (DRUG), Advil (DRUG).
Who is sponsoring clinical trial NCT01383486?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01383486's enrollment target sits among peer trials
253 1246th of 2000 higher than 755 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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