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Acetaminophen/Naproxen Sodium Dose Ranging Study

NCT04447040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2025-03-24

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Acetaminophen/naproxen sodium Dose A

Acetaminophen/naproxen sodium Dose A 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.

DRUG

Acetaminophen/naproxen sodium Dose C

Acetaminophen/naproxen sodium Dose C 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.

DRUG

Acetaminophen/naproxen sodium Dose E

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

DRUG

Placebo

Placebo tablets administered as a single two-tablet dose.

Sponsors & Collaborators

  • Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · JBR Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-04-09
Completion
2021-05-03
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 NCT04447040 on ClinicalTrials.gov