NCT02320708

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen (ACE) (1000 mg)	2 Test ACE 500 mg tablets taken orally one time
DRUG	Commercial ACE (1000 mg)	2 ACE 500 mg caplets taken orally one time
DRUG	Commercial Ibuprofen (IBU) (400 mg)	2 IBU 200 mg soft-gels taken orally one time
DRUG	Placebo	2 placebo caplets for acetaminophen taken orally one time
DRUG	Placebo	2 placebo soft-gels for ibuprofen taken orally one time
DRUG	Placebo	2 placebo tablets for Test acetaminophen taken orally one time

Timeline

• Start date: 2014-12-31
• Primary completion: 2015-04-30
• Completion: 2015-04-30
• First posted: 2014-12-19
• Last updated: 2021-12-03

Locations

1 site across 1 country: United States