Clinical trial NCT02209181: A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: dental pain
post-surgical dental pain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 269
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)
timeFrame: 6 Hours
Secondary outcomes:
measure: Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose
timeFrame: Baseline to 15 minutes post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose
timeFrame: Baseline to 30 minutes post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose
timeFrame: Baseline to 45 minutes post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose
timeFrame: Baseline to 1 hour post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose
timeFrame: Baseline to 1.5 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose
timeFrame: Baseline to 2 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose
timeFrame: Baseline to 3 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose
timeFrame: Baseline to 4 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose
timeFrame: Baseline to 5 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose
timeFrame: Baseline to 6 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose
timeFrame: Baseline to 7 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose
timeFrame: Baseline to 8 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose
timeFrame: Baseline to 9 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose
timeFrame: Baseline to 10 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose
timeFrame: Baseline to 11 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose
timeFrame: Baseline to 12 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose
timeFrame: Baseline to 16 hours post dose
measure: Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose
timeFrame: Baseline to 24 hours post dose
measure: Pain Relief (PAR) Scores at 15 Minutes Post Dose
timeFrame: 15 minutes post dose
measure: Pain Relief (PAR) Scores at 30 Minutes Post Dose
timeFrame: 30 minutes post dose
measure: Pain Relief (PAR) Scores at 45 Minutes Post Dose
timeFrame: 45 minutes post dose
measure: Pain Relief (PAR) Scores at 1 Hour Post Dose
timeFrame: 1 hour post dose
measure: Pain Relief (PAR) Scores at 1.5 Hours Post Dose
timeFrame: 1.5 hours post dose
measure: Pain Relief (PAR) Scores at 2 Hours Post Dose
timeFrame: 2 hours post dose
measure: Pain Relief (PAR) Scores at 3 Hours Post Dose
timeFrame: 3 hours post dose
measure: Pain Relief (PAR) Scores at 4 Hours Post Dose
timeFrame: 4 hours post dose
measure: Pain Relief (PAR) Scores at 5 Hours Post Dose
timeFrame: 5 hours post dose
measure: Pain Relief (PAR) Scores at 6 Hours Post Dose
timeFrame: 6 hours post dose
measure: Pain Relief (PAR) Scores at 7 Hours Post Dose
timeFrame: 7 hours post dose
measure: Pain Relief (PAR) Scores at 8 Hours Post Dose
timeFrame: 8 hours post dose
measure: Pain Relief (PAR) Scores at 9 Hours Post Dose
timeFrame: 9 hours post dose
measure: Pain Relief (PAR) Scores at 10 Hours Post Dose
timeFrame: 10 hours post dose
measure: Pain Relief (PAR) Scores at 11 Hours Post Dose
timeFrame: 11 hours post dose
measure: Pain Relief (PAR) Scores at 12 Hours Post Dose
timeFrame: 12 hours post dose
measure: Pain Relief (PAR) Scores at 16 Hours Post Dose
timeFrame: 16 hours post dose
measure: Pain Relief (PAR) Scores at 24 Hours Post Dose
timeFrame: 24 hours post dose
measure: Duration of Pain Relief After Dosing (Time to Rescue Medication)
timeFrame: Completed at time of the first rescue medication (hours post dose), estimated up through Day 2
measure: Subject Global Evaluation
timeFrame: Completed at hour 12 or at time of the first rescue medication (hours post dose).
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Derek Muse, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
name: Cathy Gelotte, Ph.D.
role: STUDY_DIRECTOR
References: