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Study of Acetaminophen (ACM) in Post-operative Dental Pain

NCT02735122 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2022-09-28

No results posted yet for this study

Summary

This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Conditions

  • Post Operative Dental Pain

Interventions

DRUG

acetaminophen Tablet

2 test acetaminophen 500 mg tablets

DRUG

acetaminophen Caplet

2 commercial acetaminophen 500 mg caplets

DRUG

ibuprofen Liquid-filled capsule

2 commercial ibuprofen 200 mg Liquid-filled capsules

DRUG

Placebo Tablet

2 placebo tablets

DRUG

Placebo Caplet

2 placebo caplets

DRUG

Placebo Liquid-filled capsule

2 placebo Liquid-filled capsules

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Derek D. Muse, M.D. · Jean Brown 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
2016-04-30
Primary Completion
2016-10-05
Completion
2016-10-05
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 NCT02735122 on ClinicalTrials.gov