Acetaminophen/Naproxen Sodium Dose Ranging Study

March 14, 2025 updated by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain

Study assessing the relative efficacy of five strengths of a fixed combination of acetaminophen and naproxen sodium is being investigated to help inform selection of dose(s) for further development and to evaluate the safety of a fixed combination of naproxen sodium and acetaminophen.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled study to evaluate the analgesic efficacy and safety profile of the following doses of a fixed combination of Acetaminophen (APAP)/Naproxen sodium (NPX) administered as a single two-tablet dose:[Acetaminophen/Naproxen Sodium Dose A, Acetaminophen/Naproxen Sodium Dose B, Acetaminophen/Naproxen Sodium Dose C, Acetaminophen/Naproxen Sodium Dose D, Acetaminophen/Naproxen Sodium Dose E and Placebo] following surgical extraction of four third molars.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
304

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Males or females 17-50 years old
  2. Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (inclusive) at screening
  3. Surgical removal of three or four third molars, of which, two must be mandibular impactions
  4. Meets requirements for post-surgical pain level
  5. Females of childbearing potential and males agree to contraceptive requirements of study
  6. Have a negative urine drug screen at screening, and on day of surgical procedure

Exclusion Criteria:

  1. Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant
  2. Have a known allergy or hypersensitivity to naproxen or other NSAIDs, including aspirin, or to acetaminophen, oxycodone or other opioids;
  3. Not able to swallow whole large tablets or capsules
  4. History of any condition (s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study
  5. Use analgesics 5 or more times per week
  6. History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years
  7. Use of any immunosuppressive drugs within 2 weeks of screening
  8. 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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose A
Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose B
Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose C
Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose D
Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
Experimental: Acetaminophen/naproxen sodium Dose E
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Drug: Acetaminophen/naproxen sodium Dose E
Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
Placebo Comparator: Placebo
Placebo tablets administered as a single two-tablet dose.
Drug: Placebo
Placebo tablets administered as a single two-tablet dose.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time Weighted Sum of Pain Intensity Difference Score From Baseline (0 Hour) to 12 Hours (SPID 0-12)
Time Frame: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time weighted sum of the pain intensity difference (SPID) score is derived from pain intensity difference (PID) score. Pain intensity-numerical rating scale (PI-NRS) was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID score was the difference between baseline pain intensity and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the interval from 0 to 12 hours. The possible range of SPID for 0 to 12 hours was from -120 to 120. A higher value of SPID indicated greater pain relief.
Baseline (0 hour) up to 12 hours post-dose on Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time Weighted Sum of Total Pain Relief Score From Baseline (0 Hour) to 12 Hours (TOTPAR 0-12)
Time Frame: Baseline (0 hour) up to 12 hours post-dose on Day 1
Time weighted total pain relief (TOTPAR) was measured using a Pain Relief Numerical Rating Scale (PR-NRS) ranging from 0 to10 (0 = no relief, 10 = complete relief). A higher score indicated greater pain relief. Total pain relief scores (TOTPARs) were calculated by multiplying the pain relief score at each post-dose time point by the duration (in hours) since the preceding time point and then summing these values. The minimum value was 0, and the maximum value was 120. Higher scores were indicative of more pain relief.
Baseline (0 hour) up to 12 hours post-dose on Day 1
Time Weighted Sum of Pain Intensity Difference Score From 6 Hours to 12 Hours (SPID 6-12)
Time Frame: From 6 hours up to 12 hours post-dose on Day 1
Time weighted sum of the pain intensity difference (SPID) score is derived from PID score. PI-NRS was used to assess pain intensity on scale ranged from 0 (no pain) to 10 (very severe pain), higher score indicated severe pain intensity. PID was the difference between pain intensity at 6 hours and pain intensity at assessment timepoint (12 hours). The SPID scores were derived by first multiplying each PID score by the time from the previous time point and adding these time weighted PID scores together over the intervals from 6 to 12 hours (6 hours). The possible range of SPID for 6 to12 hours was from -60 to 60. A higher value of SPID indicated greater pain relief.
From 6 hours up to 12 hours post-dose on Day 1
Time to First Use of Rescue Analgesic Medication
Time Frame: From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Time to first use of rescue analgesic medication was measured as the elapsed time (in minutes) from when the investigational product was given until the time rescue analgesic was first given. Participants who did not use rescue medication during the 24 hour study period had their time to rescue set to 24 hours and were censored at 24 hours. Kaplan-Meier method was used for the analysis.
From 0 minute up to 1440 minutes post-dose (that is, up to 24 hours post-dose) on Day 1
Proportion of Participants Who Required Rescue Analgesic Medication
Time Frame: From 0 hour up to 24 hours post-dose on Day 1
Proportion (cumulative data) of participants who used rescue analgesic medication through 24 hours post study drug administration on Day 1 which was assessed by using Kaplan-Meier estimates were reported.
From 0 hour up to 24 hours post-dose on Day 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Todd Bertoch, MD, JBR Clinical Research

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CCSPAA002398

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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