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

October 10, 2026 updated by: Johnson & Johnson Consumer Inc. (J&JCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

447

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • JBR Clinical Research LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening
  • Surgical removal of three or four third molars, of which, two must be mandibular impactions
  • Meets requirements for post-surgical pain level
  • Females of childbearing potential and males agree to contraceptive requirements of study
  • Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

  • Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
  • Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids
  • Not able to swallow whole large tablets or capsules
  • History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
  • Use analgesics 5 or more times per week
  • History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
  • Use any immunosuppressive drugs within 2 weeks of surgical procedure
  • History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetaminophen/Naproxen Sodium Fixed Combination

Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets.
Drug: Acetaminophen/Naproxen Sodium Fixed Combination

Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.
Active Comparator: Naproxen Sodium

Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule.
Drug: Placebo

Placebo will be administered orally.

Drug: Naproxen Sodium

Naproxen Sodium will be administered orally.
Active Comparator: Acetaminophen

Participants will receive a single oral dose of two Acetaminophen tablets.
Drug: Acetaminophen

Acetaminophen will be administered orally.
Placebo Comparator: Placebo

Participants will receive a single oral dose of two Placebo capsules.
Drug: Placebo

Placebo will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted Sum of Pain Intensity Difference From 0 to 12 Hours After Dosing (SPID 0-12)
Time Frame: Baseline (0 hour) up to 12 hours post-dose

Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity.

The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 0-12 hours. PID is ranging from 0 to 10 point and SPID 0-12 ranging from 0 to 120. A higher value of SPID indicated greater pain relief.
Baseline (0 hour) up to 12 hours post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)
Time Frame: From 6 to 12 hours

Time-weighted sum of the pain intensity difference (SPID) scores were calculated using a Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. The Pain Intensity Difference (PID) at each time point was derived by subtracting the pain intensity at that time point from the baseline pain intensity.

The SPID scores were derived by first multiplying each PID score by the time from the previous timepoint and adding these time weighted PID scores together over the intervals from 6-12 hours. PID is ranging from 0 to 10 point and SPID6-12 ranging from 0 to 60. A higher value of SPID indicated greater pain relief.
From 6 to 12 hours
Time to First Request of Rescue Analgesic
Time Frame: 0 to 24 hours

Time to first request for rescue medication was measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.
0 to 24 hours
Proportion of Subjects Who Request Rescue Analgesic During the First 12 Hours
Time Frame: Up to 12 hours

Proportion of participants who requested rescue analgesic during the first 12 hours was reported.
Up to 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Investigators

  • Study Director: Marsha Tharakan, MD, DDS, Kenvue Brands LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

May 17, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 9, 2023

Study Record Updates

Last Update Posted (Actual)

November 3, 2026

Last Update Submitted That Met QC Criteria

October 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCSPAA005199
  • CCSPAA005199 (Other Grant/Funding Number: Johnson & Johnson Consumer, Inc. (JJCI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Johnson & Johnson Consumer Inc. has an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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