Conditions: Dental Pain
Keywords: Acetaminophen Paracetamol Analgesics Analgesics Non-Narcotic Pain Postoperative Pain Antipyretics Dental Surgery Third molar extraction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 403
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

Detailed description:

Arms:
arm 1: None arm 2: Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Interventions: intervention 1: Acetaminophen ER intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose (2 tablets) Acetaminophen ER 750 mg intervention 2: Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Protocol document: