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

Phase 3 Completed 420 enrolled Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division Johnson & Johnson Consumer and Personal Products Worldwide · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start: 2016-04-30
Primary completion: 2016-10-05
Completion: 2016-10-05

Publications

Myers A, Gelotte C, Zuckerman A, Zimmerman B, Shenoy A, Qi D, Cooper SA. Analgesic onset and efficacy of a fast-acting formulation of acetaminophen in a postoperative dental impaction pain model. Curr Med Res Opin. 2024 Feb;40(2):267-277. doi: 10.1080/03007995.2023.2294946. Epub 2024 Jan 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	1000 mg	Oral
Comparator	Ibuprofen	Small molecule	400 mg	—

Indications

No indication recorded.