Phase 2
N=269
A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02209181 ↗Enrolled (actual)
269
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6) — 4.37; 20.75; 8.95; 20.56 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- JNJ-10450232 / Not yet marketed (Drug); acetaminophen / Tylenol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6) |
4.37; 20.75; 8.95; 20.56 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose |
0.13; 0.25; 0.06; 0.21 | 0.448 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose |
0.25; 1.59; 0.46; 0.71 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose |
0.28; 3.22; 0.91; 1.51 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose |
0.25; 3.98; 1.03; 2.19 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose |
0.37; 4.35; 1.23; 2.85 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose |
0.41; 4.20; 1.43; 3.48 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose |
0.71; 3.84; 1.69; 3.86 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose |
0.91; 3.78; 1.79; 4.17 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose |
1.01; 3.56; 1.82; 4.14 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose |
1.12; 3.04; 1.69; 4.07 | <0.001 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose |
1.13; 2.38; 1.66; 3.94 | 0.018 sig |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose |
1.15; 1.99; 1.51; 4.00 | 0.102 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose |
1.19; 1.69; 1.73; 3.91 | 0.338 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose |
1.08; 1.60; 1.57; 3.87 | 0.306 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose |
1.03; 1.58; 1.57; 3.70 | 0.279 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose |
1.08; 1.57; 1.39; 3.61 | 0.329 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose |
0.93; 1.37; 1.08; 3.43 | 0.380 |
| SECONDARY Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose |
1.15; 1.41; 1.29; 3.47 | 0.640 |
| SECONDARY Pain Relief (PAR) Scores at 15 Minutes Post Dose |
0.27; 0.52; 0.33; 0.38 | 0.117 |
| SECONDARY Pain Relief (PAR) Scores at 30 Minutes Post Dose |
0.60; 2.38; 0.90; 1.03 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 45 Minutes Post Dose |
0.64; 4.42; 1.52; 2.11 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 1 Hour Post Dose |
0.84; 5.18; 1.68; 3.09 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 1.5 Hours Post Dose |
1.01; 5.88; 2.13; 3.97 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 2 Hours Post Dose |
1.17; 5.88; 2.53; 4.90 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 3 Hours Post Dose |
1.59; 5.39; 2.90; 5.40 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 4 Hours Post Dose |
1.92; 5.31; 2.99; 5.83 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 5 Hours Post Dose |
2.17; 5.00; 3.05; 5.77 | <0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 6 Hours Post Dose |
2.32; 4.42; 2.92; 5.68 | 0.001 sig |
| SECONDARY Pain Relief (PAR) Scores at 7 Hours Post Dose |
2.41; 3.62; 2.80; 5.57 | 0.067 |
| SECONDARY Pain Relief (PAR) Scores at 8 Hours Post Dose |
2.41; 3.10; 2.63; 5.62 | 0.281 |
| SECONDARY Pain Relief (PAR) Scores at 9 Hours Post Dose |
2.46; 2.73; 2.98; 5.50 | 0.674 |
| SECONDARY Pain Relief (PAR) Scores at 10 Hours Post Dose |
2.28; 2.67; 2.81; 5.40 | 0.541 |
| SECONDARY Pain Relief (PAR) Scores at 11 Hours Post Dose |
2.26; 2.63; 2.75; 5.25 | 0.573 |
| SECONDARY Pain Relief (PAR) Scores at 12 Hours Post Dose |
2.34; 2.57; 2.53; 5.16 | 0.720 |
| SECONDARY Pain Relief (PAR) Scores at 16 Hours Post Dose |
2.09; 2.23; 2.07; 4.96 | 0.821 |
| SECONDARY Pain Relief (PAR) Scores at 24 Hours Post Dose |
2.44; 2.20; 2.33; 4.96 | 0.726 |
| SECONDARY Duration of Pain Relief After Dosing (Time to Rescue Medication) |
109.0; 468.5; 129.0; NA | 0.042 sig |
| SECONDARY Subject Global Evaluation |
62.7; 12.1; 55.1; 28.8; 14.9; 9.1 | <0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02209181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.