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Study of Long-Acting Acetaminophen in Postoperative Dental Pain

NCT01960114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2015-07-10

Study results available
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Summary

The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

Conditions

  • Dental Pain

Interventions

DRUG

Acetaminophen ER

Single dose (2 tablets) Acetaminophen ER 750 mg

DRUG

Placebo

Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • McNeil 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
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT01960114 on ClinicalTrials.gov