Conditions: Pain, Postoperative
Keywords: Naproxen Sodium, dental pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: yes

Brief summary:
The objective is to evaluate pain relief of the extended release naproxen sodium 660 mg tablet compared to commercial naproxen sodium 220 mg tablet over 24 hours in patients with postsurgical dental pain.

Detailed description:

Arms:
arm 1: 1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min) arm 2: 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min) arm 3: 1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)

Interventions: intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Naproxen Sodium IR (Aleve, BAYH6689) intervention 3: Naproxen Sodium ER Placebo intervention 4: Naproxen Sodium IR Placebo
Intervention descriptions: intervention 1: 660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours intervention 2: 220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours intervention 3: Matching placebo of 660 mg Naproxen Sodium ER for 24 hours intervention 4: Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours

Protocol document: