drugset / Trial / NCT01427803

Actual Use Trial of Naproxen Sodium

NCT01427803

Phase 3 Completed 778 enrolled Bayer
RandomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-09
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Naproxen Small molecule Oral

Indications

No indication recorded.