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

Completed · Phase 3 · Has a placebo group

Conditions studied: Post Operative Dental Pain

In brief

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.

Key facts

Study ID

NCT02735122

Run by

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

People needed

420

Starts

2016-04-30

Expected to finish

2016-10-05

Last updated by the study team

2022-09-28

Who can join

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

You may qualify if…

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

You may not qualify if…

• Currently pregnant or planning to be pregnant or nursing a baby
• Known allergy to acetaminophen (ACM) 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

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.