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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.

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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

FieldValue
Enrollment Target 778 participants
Start Date 2011-09
Est. Completion 2011-12
Phase Phase 3

Sponsor

Bayer

591 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.