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

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: acetaminophen / Tylenol; Drug: JNJ-10450232 / Not yet marketed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209181

CO-131230135611-CTPA

Details and patient eligibility

About

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.

Full 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 single dose in capsules (250 or 1000 mg), over a 24 hour period after molar extractions. Subjects will stay at the research center for ~24 hours after administration of study drug. Healthy male subjects, ages 18 to 45 years inclusive, will be screened by medical history, vital signs, an electrocardiogram (ECG), and clinical laboratory tests. Eligible subjects will return to the clinic on the day of surgery and complete baseline vital signs and clinical laboratory tests. They will undergo dental extraction of a minimum of three third-molars and, if qualified, will be randomly assigned to one of four study treatments for pain.

Enrollment: 269 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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269 participants in 4 patient groups, including a placebo group

JNJ-10450232 250 mg

Experimental group

Treatment:

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

JNJ-10450232 1000 mg

Experimental group

Treatment:

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

Placebo

Placebo Comparator group

Treatment:

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

Drug: JNJ-10450232 / Not yet marketed

Acetaminophen 1000 mg

Active Comparator group

Treatment:

Drug: acetaminophen / Tylenol