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Completed

NCT Number: NCT05761574

A 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.

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Key information

Conditions

Pain Facial Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases Tooth Diseases Toothache

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

JBR Clinical Research LLC

Salt Lake City, Utah, 84107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen/Naproxen Sodium Fixed Combination

Drug

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

Naproxen sodium

Drug

Naproxen Sodium will be administered orally.

Acetaminophen

Drug

Acetaminophen will be administered orally.

Placebo

Drug

Placebo will be administered orally.

Primary outcomes

  1. Time-weighted Sum of Pain Intensity Difference from 0 to 12 Hours After Dosing (SPID 0-12)

    Time frame: 0 to 12 hours

    Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the 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.

Secondary outcomes

  1. Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12)

    Time frame: 6 to 12 hours

    Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe.

  2. Time to First Request of Rescue Analgesic

    Time frame: 0 to 24 hours

    Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested.

  3. Percentage of Participants who Request Rescue Analgesic During the First 12 hours

    Time frame: 0 to 12 hours

    Percentage of participants who request rescue analgesic during the first 12 hours will be reported.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc. (J&JCI)

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 9, 2023
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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