NCT04018612

A Study of Acetaminophen for Post Surgical Dental Pain

A Randomized, Double-Blind, Multi-Dose, Single-Site, Placebo- and Active-Controlled, Efficacy, Tolerability, Safety and Pharmacokinetic Study of Two Different Dosing Regimens of Acetaminophen in Post-Surgical Dental Pain.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Nevakar, Inc. · Industry
• Sex: All
• Age: 17 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To assess the safety, tolerability, analgesic, efficacy and pharmacokinetics of high dose acetaminophen relative to placebo and low dose acetaminophen relative to placebo over a 24 hour period in patient experiencing moderate to severe pain following the surgical removal of third molar.

Detailed description

This will be a randomized, double-blind, single-site, placebo-controlled, parallel-group study to assess similarities in safety, tolerability, efficacy, and pharmacokinetics of high dose acetaminophen given relative to placebo, and low dose acetaminophen given relative to placebo over a 24-hour period in patients experiencing moderate to severe postsurgical pain within 7 hours following surgical removal of 2 or more molars

Conditions

• Pain, Postoperative
• Dental Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen	Acetaminophen is an analgesic and antipyretic
OTHER	Placebo	Saline

Timeline

• Start date: 2019-04-25
• Primary completion: 2019-07-26
• Completion: 2019-08-15
• First posted: 2019-07-12
• Last updated: 2022-03-29
• Results posted: 2022-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study