NCT03879408

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · Industry
• Sex: All
• Age: 17 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	440 mg naproxen sodium with 1000 mg acetaminophen	440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
DRUG	220 mg naproxen sodium with 650 mg acetaminophen	220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
DRUG	10 mg hydrocodone + 650 mg acetaminophen	10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
DRUG	440 mg naproxen sodium	440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
DRUG	Placebo tablet	Single dose of four placebo tablets

Timeline

• Start date: 2019-05-28
• Primary completion: 2019-11-07
• Completion: 2019-11-13
• First posted: 2019-03-18
• Last updated: 2022-12-05
• Results posted: 2022-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study