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Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study

NCT03879408 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2022-12-05

Study results available
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Summary

Study assessing efficacy and safety of concomitantly dosed naproxen sodium with acetaminophen, compared with naproxen sodium, hydrocodone/acetaminophen and Placebo in a postoperative dental pain.

Conditions

Interventions

DRUG

440 mg naproxen sodium with 1000 mg acetaminophen

440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets

DRUG

220 mg naproxen sodium with 650 mg acetaminophen

220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet

DRUG

10 mg hydrocodone + 650 mg acetaminophen

10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets

DRUG

440 mg naproxen sodium

440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets

DRUG

Placebo tablet

Single dose of four placebo tablets

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Todd Bertoch, MD · Jean Brown Research (JBR)

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
2019-05-28
Primary Completion
2019-11-07
Completion
2019-11-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03879408 on ClinicalTrials.gov