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

CompletedPhase 3

Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Conditions: Post Operative Dental Pain

Interventions: acetaminophen Tablet, acetaminophen Caplet, ibuprofen Liquid-filled capsule, Placebo Tablet, Placebo Caplet

Countries: United States

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Eligibility overview

Sex: ALL

Age: 17 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. 17 years to 50 years old
2. Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive
3. Dental extraction of three or four molars
4. Experience moderate to severe pain after extraction of third molars
5. Females of childbearing age must be willing to use acceptable method of birth control

Exclusion Criteria:

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

Locations (1)

Salt Lake City, Utah, United States