NCT05761574

A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 447 (actual)
• Sponsor: Johnson & Johnson Consumer Inc. (J&JCI) · Industry
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Detailed description

This is a randomized, double-blind, placebo-controlled, single-dose full-factorial study to evaluate the analgesic efficacy and safety of a fixed combination of acetaminophen and naproxen sodium, compared with acetaminophen or naproxen sodium alone, and placebo following surgical extraction of three or four third molars.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Acetaminophen/Naproxen Sodium Fixed Combination	Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
DRUG	Naproxen Sodium	Naproxen Sodium will be administered orally.
DRUG	Acetaminophen	Acetaminophen will be administered orally.
DRUG	Placebo	Placebo will be administered orally.

Timeline

• Start date: 2023-05-22
• Primary completion: 2024-05-17
• Completion: 2024-05-30
• First posted: 2023-03-09
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study