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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 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 778 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01427803
The ClinicalTrials.gov registry entry for NCT01427803 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 778 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Naproxen Sodium ER (BAYH6689) is the first listed.
NCT01427803 reports 0 study locations.
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.
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