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

NCT05761574 | Completed Phase 3 FDA Drug

• 1 other identifier: CCSPAA005199
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Analgesics; Dental Pain; Acetaminophen; Naproxen Sodium; Pain; Fixed-Dose

Outcome Measures

Primary Outcomes (1)

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

  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.

  0 to 12 hours

Secondary Outcomes (3)

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

  6 to 12 hours

• Time to First Request of Rescue Analgesic

  0 to 24 hours

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

  0 to 12 hours

Study Arms (4)

Acetaminophen/Naproxen Sodium Fixed Combination

EXPERIMENTAL

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

Drug: Acetaminophen/Naproxen Sodium Fixed Combination

Naproxen Sodium

ACTIVE COMPARATOR

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

Drug: Naproxen Sodium; Drug: Placebo

Acetaminophen

ACTIVE COMPARATOR

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

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Acetaminophen/Naproxen Sodium Fixed Combination DRUG

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

Acetaminophen/Naproxen Sodium Fixed Combination

Naproxen Sodium DRUG

Naproxen Sodium will be administered orally.

Naproxen Sodium

Acetaminophen DRUG

Acetaminophen will be administered orally.

Acetaminophen

Placebo DRUG

Placebo will be administered orally.

Naproxen Sodium; Placebo

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Consumer Inc. (J&JCI): lead

Study Sites (1)

JBR Clinical Research LLC

Salt Lake City, Utah, 84107, United States

Location

Related Publications (21)

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• Product Monograph for Aleve (Naproxen Sodium Tablets USP/Liquid Gels/Capsules 220 mg). Bayer Inc. Consumer Care. Revised 8 January 2015

  BACKGROUND

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  PMID: 20336423 BACKGROUND

• Cooper SA, Desjardins PJ, Turk DC, Dworkin RH, Katz NP, Kehlet H, Ballantyne JC, Burke LB, Carragee E, Cowan P, Croll S, Dionne RA, Farrar JT, Gilron I, Gordon DB, Iyengar S, Jay GW, Kalso EA, Kerns RD, McDermott MP, Raja SN, Rappaport BA, Rauschkolb C, Royal MA, Segerdahl M, Stauffer JW, Todd KH, Vanhove GF, Wallace MS, West C, White RE, Wu C. Research design considerations for single-dose analgesic clinical trials in acute pain: IMMPACT recommendations. Pain. 2016 Feb;157(2):288-301. doi: 10.1097/j.pain.0000000000000375.

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• Cheung R, Krishnaswami S, Kowalski K. Analgesic efficacy of celecoxib in postoperative oral surgery pain: a single-dose, two-center, randomized, double-blind, active- and placebo-controlled study. Clin Ther. 2007;29 Suppl:2498-510. doi: 10.1016/j.clinthera.2007.12.008.

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  PMID: 17933588 BACKGROUND

• Clinical Study Report CCSPAA001068. A randomized, double-blind, placebo- and activecontrolled, proof of concept study to evaluate two strengths of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and placebo in postoperative dental pain.: Johnson & Johnson Consumer, Inc., May 2019.

  BACKGROUND

• Clinical Study Report CCSPAA002398. A Randomized, Double-blind, Placebo-controlled Study to Evaluate Five Strengths of a Fixed Combination of Acetaminophen/Naproxen Sodium in Postoperative Dental Pain.: Johnson & Johnson Consumer, Inc., November 2020.

  BACKGROUND

• 21 CFR § 300.50 - Fixed-combination prescription drugs for humans, 40 FR 13496, Mar. 27, 1975, as amended at 64 FR 401, Jan. 5, 1999.

  BACKGROUND

• Little RJ, Rubin DB. Statistical analysis with missing data: John Wiley & Sons; 2002.

  BACKGROUND

MeSH Terms

Conditions

Pain; Toothache

Interventions

Acetaminophen; Naproxen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Todd Bertoch

  JBR Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post-operative dental pain following third molar extraction.

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: May 22, 2023
• Primary Completion: May 17, 2024
• Study Completion: May 30, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)