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COMPLETEDPhase 2NCT02320708

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

This is a dental pain study evaluating the efficacy and safety of a single dose of test acetaminophen (ACE) (1000 mg) compared to commercial acetaminophen (1000 mg), ibuprofen (IBU) (400 mg), and plac...

Lead sponsor: Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.

Collaborators

Johnson & Johnson Consumer and Personal Products Worldwide

Age

17 - 50 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Are 17 to 50 years of age
•2. Weigh 100 lbs or greater and body mass index (BMI) 18 to 30 (inclusive)
•3. Dental extraction of three or four third-molars.
•4. Experience moderate to severe pain after extraction of third molars

Exclusion Criteria

•1. Currently pregnant (or planning to be pregnant) or nursing a baby
•2. Known allergy to acetaminophen (ACE) or non-steroidal anti-inflammatory drugs (NSAIDs)
•3. Inability to swallow whole large tablets or capsules
•4. Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 3, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment240

Start dateDec 2014

Last updatedDec 3, 2021

Condition

Locations shown

Jean Brown Research

Salt Lake City, Utah

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2021Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions