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

NCT05761574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 447

Last updated 2025-07-02

No results posted yet for this study

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

Interventions

DRUG

Acetaminophen/Naproxen Sodium Fixed Combination

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

DRUG

Naproxen Sodium

Naproxen Sodium will be administered orally.

DRUG

Acetaminophen

Acetaminophen will be administered orally.

DRUG

Placebo

Placebo will be administered orally.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch · JBR Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2024-05-17
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05761574 on ClinicalTrials.gov