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Completed Phase 2 Interventional Results available

Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

ClinicalTrials.gov ID: NCT03879408

Public ClinicalTrials.gov record NCT03879408. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 4, 2026, 5:19 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Study identification

NCT ID
NCT03879408
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Industry
Enrollment
290 participants

Conditions and interventions

Conditions

Interventions

  • 10 mg hydrocodone + 650 mg acetaminophen Drug
  • 220 mg naproxen sodium with 650 mg acetaminophen Drug
  • 440 mg naproxen sodium Drug
  • 440 mg naproxen sodium with 1000 mg acetaminophen Drug
  • Placebo tablet Drug

Drug

Eligibility (public fields only)

Age range
17 Years to 50 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 27, 2019
Primary completion
Nov 6, 2019
Completion
Nov 12, 2019
Last update posted
Dec 4, 2022

2019

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Jean Brown Research Clinical Research Salt Lake City Utah 84107

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03879408, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 4, 2022 · Synced May 4, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03879408 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →