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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
269
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Jean Brown Research
Salt Lake City, Utah, United States
Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
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).
Time frame: 6 Hours
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 15 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 30 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 45 minutes post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
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Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
Time frame: Baseline to 1 hour post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 1.5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 2 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 3 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 4 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 5 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 6 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 7 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 8 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 9 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 10 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 11 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 12 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 16 hours post dose
Pain Intensity Difference From Baseline (PID) Scores at 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.
Time frame: Baseline to 24 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 15 minutes post dose
Pain Relief (PAR) Scores at 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).
Time frame: 30 minutes post dose
Pain Relief (PAR) Scores at 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).
Time frame: 45 minutes post dose
Pain Relief (PAR) Scores at 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).
Time frame: 1 hour post dose
Pain Relief (PAR) Scores at 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).
Time frame: 1.5 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 2 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 3 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 4 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 5 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 6 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 7 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 8 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 9 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 10 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 11 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 12 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 16 hours post dose
Pain Relief (PAR) Scores at 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).
Time frame: 24 hours post dose
Duration of Pain Relief After Dosing (Time to Rescue Medication)
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.
Time frame: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2
Subject Global Evaluation
How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).
Time frame: Completed at hour 12 or at time of the first rescue medication (hours post dose).