An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID (Kiefer AUT)

NCT01427803 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	778
Start date	2011-09
Completion	2011-12

Conditions

• Pain

Interventions

• Naproxen Sodium ER (BAYH6689)

Primary outcomes

• Estimated Percentage of Misuse for Non-Therapeutic Reasons — 28 days
  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.

Countries

United States