NCT02735122

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

A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Conditions

• Post Operative Dental Pain

Interventions

Type	Name	Description
DRUG	acetaminophen Tablet	2 test acetaminophen 500 mg tablets
DRUG	acetaminophen Caplet	2 commercial acetaminophen 500 mg caplets
DRUG	ibuprofen Liquid-filled capsule	2 commercial ibuprofen 200 mg Liquid-filled capsules
DRUG	Placebo Tablet	2 placebo tablets
DRUG	Placebo Caplet	2 placebo caplets
DRUG	Placebo Liquid-filled capsule	2 placebo Liquid-filled capsules

Timeline

• Start date: 2016-04-30
• Primary completion: 2016-10-05
• Completion: 2016-10-05
• First posted: 2016-04-12
• Last updated: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study