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Completed

NCT Number: NCT04447040

Acetaminophen/Naproxen Sodium Dose Ranging Study

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.

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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

17 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males or females 17-50 years old
  • Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5-35.4 (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 of any immunosuppressive drugs within 2 weeks of screening
  • History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

Treatment and study plan

Acetaminophen/naproxen sodium Dose A

Drug

Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose B

Drug

Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose C

Drug

Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose D

Drug

Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.

Acetaminophen/naproxen sodium Dose E

Drug

Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.

Placebo

Drug

Placebo tablets administered as a single two-tablet dose.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 25, 2020
Registry last updated
Mar 24, 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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