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Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

NCT03566979 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2020-04-09

Study results available
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Summary

To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Conditions

  • Post-operative Dental Pain

Interventions

DRUG

Test naproxen sodium tablet

Single dose of 2 test naproxen sodium 220 mg tablets

DRUG

Commercial naproxen sodium tablet

Single dose of 2 naproxen sodium 220 mg tablets

DRUG

Commercial naproxen sodium liquid gels capsule

Single dose of 2 naproxen sodium 220 mg liquid gel capsules

DRUG

Placebo tablet

2 placebo tablets

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Todd M 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
2018-08-13
Primary Completion
2019-03-26
Completion
2019-04-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03566979 on ClinicalTrials.gov