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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pain

In brief

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.

Key facts

Study ID

NCT02209181

Run by

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

People needed

269

Starts

2014-08-01

Expected to finish

2015-04-01

Last updated by the study team

2017-02-03

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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