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

Phase 2

Completed

Conditions: Pain

Interventions: Drug: JNJ-10450232 / Not yet marketed
Drug: acetaminophen / Tylenol

Registration Number: NCT02209181

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

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 surgical removal of third molars. The primary endpoint will evaluate pain relief effectiveness up to 6 hours after administration of the study drug.

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 269

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JNJ-10450232 250 mg	JNJ-10450232 / Not yet marketed	-
JNJ-10450232 1000 mg	JNJ-10450232 / Not yet marketed	-
Placebo	JNJ-10450232 / Not yet marketed	-
Acetaminophen 1000 mg	acetaminophen / Tylenol	-

Primary Outcome Measures

Name	Time	Method
Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)	6 Hours	Time-weighted sum of pain intensity difference by first multiplying each pain intensity difference (PID) score by the time from the previous time point, and adding them together for each scheduled time point within 0-6 hours. Time points included 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 5 hours, and 6 hours. The minimum SPID 0-6 was -30 and the maximum SPID 0-6 was 60, where higher is better. Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain).

Secondary Outcome Measures

Name	Time	Method
Pain Relief (PAR) Scores at 4 Hours Post Dose	4 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	Baseline to 15 minutes post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	Baseline to 1 hour post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	Baseline to 1.5 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	Baseline to 2 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	Baseline to 3 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	Baseline to 30 minutes post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	Baseline to 45 minutes post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	Baseline to 4 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	Baseline to 5 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	Baseline to 6 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	Baseline to 7 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	Baseline to 8 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	Baseline to 9 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	Baseline to 10 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	Baseline to 11 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	Baseline to 12 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	Baseline to 16 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	Baseline to 24 hours post dose	Pain intensity is the amount of pain experienced on a scale of 1-10 (where 1=no pain and 10=very severe pain). The PID will be derived by subtracting the pain intensity from the baseline pain intensity.
Pain Relief (PAR) Scores at 15 Minutes Post Dose	15 minutes post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 30 Minutes Post Dose	30 minutes post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 45 Minutes Post Dose	45 minutes post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 1 Hour Post Dose	1 hour post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 1.5 Hours Post Dose	1.5 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 2 Hours Post Dose	2 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 3 Hours Post Dose	3 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 5 Hours Post Dose	5 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 6 Hours Post Dose	6 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 7 Hours Post Dose	7 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 8 Hours Post Dose	8 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 9 Hours Post Dose	9 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 10 Hours Post Dose	10 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 11 Hours Post Dose	11 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 12 Hours Post Dose	12 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 16 Hours Post Dose	16 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Pain Relief (PAR) Scores at 24 Hours Post Dose	24 hours post dose	Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).
Duration of Pain Relief After Dosing (Time to Rescue Medication)	Completed at time of the first rescue medication (hours post dose), estimated up through Day 2	Time (minutes) to rescue medication was measured as the elapsed time from when the investigational product was given until the time rescue medication was given.
Subject Global Evaluation	Completed at hour 12 or at time of the first rescue medication (hours post dose).	How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).