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Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

Pain Clinical Trial

Official title:
Randomized, Double-Blind, Placebo And Active Controlled, Study To Evaluate Two Strengths Of Concomitantly Dosed Naproxen Sodium With Acetaminophen, Compared With Naproxen Sodium and Hydrocodone/Acetaminophen In Postoperative Dental Pain

Clinical Trial Summary

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Clinical Trial Description

This is a randomized, double-blind, placebo- and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of concomitantly administered naproxen sodium 440 mg with acetaminophen 1000 mg and concomitantly administered naproxen sodium 220 mg with acetaminophen 650 mg, compared with a fixed combination of hydrocodone 10 mg/acetaminophen 650 mg, naproxen sodium 440 mg, and placebo over a twelve-hour period after surgical extraction of four third molars. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03879408
Study type Interventional
Source Johnson & Johnson Consumer and Personal Products Worldwide
Contact
Status Completed
Phase Phase 2
Start date May 28, 2019
Completion date November 13, 2019
View Details
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