Conditions: Pain
Keywords: Actual Use Trial
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 778
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Naproxen Sodium ER (BAYH6689)
Intervention descriptions: intervention 1: BAYH6689; oral tablet used as needed upon incidence of pain

Protocol document: