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Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

NCT03224403 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2021-04-15

Study results available
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Summary

To evaluate analgesic onset, efficacy, and safety of 1000 mg acetaminophen administered as two Test Acetaminophen 500 mg tablets (Test ACM) compared with 1000 mg acetaminophen administered as two commercial acetaminophen 500 mg caplets (ACM) and 400 mg ibuprofen administered as two commercial ibuprofen 200 mg liquid-filled capsules (IBU) in the dental pain model following third-molar extractions.

Conditions

  • Post-operative Dental Pain

Interventions

DRUG

Test acetaminophen

single dose of 2 Test acetaminophen 500 mg tablets

DRUG

Commercial acetaminophen

single dose of 2 acetaminophen 500 mg caplets

DRUG

Commercial ibuprofen

Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules

DRUG

Placebo

2 placebo caplets

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Derek Muse · Jean Brown Research/ BB Holdings

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
2017-07-19
Primary Completion
2018-04-04
Completion
2018-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03224403 on ClinicalTrials.gov