Study of Long-Acting Acetaminophen in Postoperative Dental Pain

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain

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.

Inclusion Criteria:

• Must be at least 17 and less than 46 years of age
• Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
• Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed.
• Experiencing moderate to severe pain after extraction of third molars.

Exclusion Criteria:

• Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen).
• Cannot be pregnant (or planning to be pregnant) or nursing a baby
• Unable to swallow whole large tablets or caplets.
• Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.