Study of Long-Acting Acetaminophen in Postoperative Dental Pain

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: Placebo; Drug: Acetaminophen ER

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960114

AERPAI2001

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 17 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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403 participants in 2 patient groups, including a placebo group

Acetaminophen ER

Experimental group

Treatment:

Drug: Acetaminophen ER

Placebo

Placebo Comparator group

Description:

Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Treatment:

Drug: Placebo