Study of Acetaminophen (ACE) in Post-operative Dental Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Pain

In brief

This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.

Key facts

Study ID

NCT02320708

Run by

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

People needed

240

Starts

2014-12-31

Expected to finish

2015-04-30

Last updated by the study team

2021-12-03

Who can join

Age: 17 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Are 17 to 50 years of age
• Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
• Dental extraction of three or four third-molars.
• Experience moderate to severe pain after extraction of third molars

You may not qualify if…

• Currently pregnant (or planning to be pregnant) or nursing a baby
• Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs (NSAIDs)
• Inability to swallow whole large tablets or capsules
• Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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