A Randomized, Double-blind, Placebo- and Active-controlled Trial to Investigate the Single-dose Efficacy, Safety, and Pharmacokinetics of 250 and 1000 mg JNJ-10450232 in Postoperative Dental Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 269
- Locations
- 1
- Primary Endpoint
- Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
JNJ-10450232 250 mg
Intervention: JNJ-10450232 / Not yet marketed (Drug)
JNJ-10450232 1000 mg
Intervention: JNJ-10450232 / Not yet marketed (Drug)
Placebo
Intervention: JNJ-10450232 / Not yet marketed (Drug)
Acetaminophen 1000 mg
Intervention: acetaminophen / Tylenol (Drug)
Outcomes
Primary Outcomes
Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
Time Frame: 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 Outcomes
- Pain Relief (PAR) Scores at 4 Hours Post Dose(4 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose(Baseline to 15 minutes post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose(Baseline to 1 hour post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose(Baseline to 1.5 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose(Baseline to 2 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose(Baseline to 3 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose(Baseline to 30 minutes post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose(Baseline to 45 minutes post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose(Baseline to 4 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose(Baseline to 5 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose(Baseline to 6 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose(Baseline to 7 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose(Baseline to 8 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose(Baseline to 9 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose(Baseline to 10 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose(Baseline to 11 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose(Baseline to 12 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose(Baseline to 16 hours post dose)
- Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose(Baseline to 24 hours post dose)
- Pain Relief (PAR) Scores at 15 Minutes Post Dose(15 minutes post dose)
- Pain Relief (PAR) Scores at 30 Minutes Post Dose(30 minutes post dose)
- Pain Relief (PAR) Scores at 45 Minutes Post Dose(45 minutes post dose)
- Pain Relief (PAR) Scores at 1 Hour Post Dose(1 hour post dose)
- Pain Relief (PAR) Scores at 1.5 Hours Post Dose(1.5 hours post dose)
- Pain Relief (PAR) Scores at 2 Hours Post Dose(2 hours post dose)
- Pain Relief (PAR) Scores at 3 Hours Post Dose(3 hours post dose)
- Pain Relief (PAR) Scores at 5 Hours Post Dose(5 hours post dose)
- Pain Relief (PAR) Scores at 6 Hours Post Dose(6 hours post dose)
- Pain Relief (PAR) Scores at 7 Hours Post Dose(7 hours post dose)
- Pain Relief (PAR) Scores at 8 Hours Post Dose(8 hours post dose)
- Pain Relief (PAR) Scores at 9 Hours Post Dose(9 hours post dose)
- Pain Relief (PAR) Scores at 10 Hours Post Dose(10 hours post dose)
- Pain Relief (PAR) Scores at 11 Hours Post Dose(11 hours post dose)
- Pain Relief (PAR) Scores at 12 Hours Post Dose(12 hours post dose)
- Pain Relief (PAR) Scores at 16 Hours Post Dose(16 hours post dose)
- Pain Relief (PAR) Scores at 24 Hours Post Dose(24 hours post dose)
- 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)
- Subject Global Evaluation(Completed at hour 12 or at time of the first rescue medication (hours post dose).)