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

NCT02320708 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-12-03

No results posted yet for this study

Summary

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 placebo over a 6 hour period. Subjects will undergo dental extraction of three or four third molars.

Conditions

  • Dental Pain

Interventions

DRUG

Acetaminophen (ACE) (1000 mg)

2 Test ACE 500 mg tablets taken orally one time

DRUG

Commercial ACE (1000 mg)

2 ACE 500 mg caplets taken orally one time

DRUG

Commercial Ibuprofen (IBU) (400 mg)

2 IBU 200 mg soft-gels taken orally one time

DRUG

Placebo

2 placebo caplets for acetaminophen taken orally one time

DRUG

Placebo

2 placebo soft-gels for ibuprofen taken orally one time

DRUG

Placebo

2 placebo tablets for Test acetaminophen taken orally one time

Sponsors & Collaborators

  • Johnson & Johnson Consumer and Personal Products Worldwide

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Study Director · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

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
2014-12-31
Primary Completion
2015-04-30
Completion
2015-04-30

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 NCT02320708 on ClinicalTrials.gov