Conditions: Toothache
Keywords: Dental Pain Analgesia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 312
Healthy volunteers: yes

Brief summary:
To evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.

Detailed description:

Arms:
arm 1: single dose (1 tablet) ER Naproxen sodium 660 mg with a full glass of water (240ml) within 1 - 4 hours post dental surgery. arm 2: Single dose (1 tablet) of placebo with a full glass of water (240ml) within 1 - 4 hours post dental surgery.

Interventions: intervention 1: Naproxen Sodium ER (BAYH6689) intervention 2: Placebo
Intervention descriptions: intervention 1: Analgesic efficacy in dental pain; per oral; 1 tablet extended release Naproxen Sodium; with a full glass of water within 4 hours post surgery intervention 2: Inactive ingredient; per oral; 1 lactose based tablet; with a full glass of water within 4 hours post surgery

Protocol document: