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NCT01427803 · ClinicalTrials.gov registry record · Phase 3
Actual Use Trial of Naproxen Sodium
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 778
- Enrollment target
NCT01427803: Completed Phase 3 study, sponsored by Bayer.
NCT01427803 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 778 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427803, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 778 participants
- Enrollment target
Study 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.
Primary Outcome
The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.
Interventions
- DRUG Naproxen Sodium ER (BAYH6689)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 778 participants |
| Start Date | 2011-09 |
| Est. Completion | 2011-12 |
| Phase | Phase 3 |
What the finished NCT01427803 record still lists
NCT01427803 is an interventional study that assigns participants to a tested intervention. The registered 778 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which Naproxen Sodium ER (BAYH6689) is the first listed.
NCT01427803 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01427803 about?
NCT01427803 is a clinical study titled "Actual Use Trial of Naproxen Sodium". 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) ...
What is the current status of trial NCT01427803?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 778 participants. The study started on 2011-09. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01427803?
The interventions under investigation include: Naproxen Sodium ER (BAYH6689) (DRUG).
Who is sponsoring clinical trial NCT01427803?
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 NCT01427803's enrollment target sits among peer trials
778 438th of 2000 higher than 1,563 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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