Conditions: Pain
Keywords: Self Selection Tria
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 253
Healthy volunteers: yes

Brief summary:
A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Detailed description:

Arms:
arm 1: Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.

Interventions: intervention 1: Naproxen sodium ER (BAYH6689) intervention 2: Advil
Intervention descriptions: intervention 1: Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain intervention 2: Commercially available Advil; oral caplet upon incidence of pain

Protocol document: