Status:
COMPLETED
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Lead Sponsor:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Conditions:
Pain
Eligibility:
MALE
18-45 years
Phase:
PHASE2
Brief 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 s...
Detailed Description
This is a single-center, randomized, double-blind, placebo- and active-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetic profile of JNJ-10450232, administered as a ...
Eligibility Criteria
Inclusion
- Subjects aged 18-45 years
- At least moderate dental pain assessed by a categorical scale pain intensity scale and a score of at least 5 on the 11-point (0-10) pain intensity numerical rating scale (PI-NRS) following surgical removal of three third-molars
Exclusion
- Subjects who are not otherwise healthy
- Test positive for the urine drug screen
- Taking prohibited medications will not be allowed to participate in this study
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT02209181
Start Date
August 1 2014
End Date
April 1 2015
Last Update
February 3 2017
Active Locations (1)
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1
Jean Brown Research
Salt Lake City, Utah, United States, 84124