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A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine

NCT02209181 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2017-02-03

Study results available
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Summary

To assess the safety and effectiveness one dose of a new pain reliever medicine (JNJ-10450232 at either the 250 or 1000 mg strength) compared with placebo (sugar pill) or acetaminophen 1000 mg after surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

Conditions

Interventions

DRUG

JNJ-10450232 / Not yet marketed

Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

DRUG

JNJ-10450232 / Not yet marketed

Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

DRUG

JNJ-10450232 / Not yet marketed

Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

DRUG

acetaminophen / Tylenol

Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Derek Muse, MD · Jean Brown Research

  • Cathy Gelotte, Ph.D. · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02209181 on ClinicalTrials.gov