NCT03224403

Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Detailed description

This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test ACM 1000 mg compared with two commercial products over a four-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	Test acetaminophen	single dose of 2 Test acetaminophen 500 mg tablets
DRUG	Commercial acetaminophen	single dose of 2 acetaminophen 500 mg caplets
DRUG	Commercial ibuprofen	Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules
DRUG	Placebo	2 placebo caplets

Timeline

• Start date: 2017-07-19
• Primary completion: 2018-04-04
• Completion: 2018-04-12
• First posted: 2017-07-21
• Last updated: 2021-04-15
• Results posted: 2021-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study