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

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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