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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02209181

Enrollment

269

Registered

2014-08-05

Start date

2014-08-31

Completion date

2015-04-30

Last updated

2017-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

dental pain, post-surgical dental pain

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.

Interventions

DRUGJNJ-10450232 / Not yet marketed

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.

DRUGacetaminophen / Tylenol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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 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 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 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 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 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).
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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo Three placebo capsules taken orally	67
Acetaminophen 1000 mg Two encapsulated 500 mg tablets and one placebo capsule taken orally	67
JNJ-10450232 250 mg One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	69
JNJ-10450232 1000 mg One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally	66
Total	269

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Adverse Event	1	0	1	0
Overall Study	Withdrawal by Subject	0	1	0	0

Baseline characteristics

Characteristic	Placebo	Acetaminophen 1000 mg	JNJ-10450232 250 mg	JNJ-10450232 1000 mg	Total
Age, Continuous	19.2 years STANDARD_DEVIATION 2.69	19.0 years STANDARD_DEVIATION 1.64	19.0 years STANDARD_DEVIATION 2.13	19.3 years STANDARD_DEVIATION 1.95	19.1 years STANDARD_DEVIATION 2.13
Gender Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Gender Male	67 Participants	67 Participants	69 Participants	66 Participants	269 Participants
Region of Enrollment USA	67 participants	67 participants	69 participants	66 participants	269 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	3 / 67	5 / 67	3 / 69	5 / 66
serious Total, serious adverse events	0 / 67	0 / 67	0 / 69	0 / 66

Outcome results

Primary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)	4.37 units on a scale	Standard Error 1.783
Acetaminophen 1000 mg	Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)	20.75 units on a scale	Standard Error 1.783
JNJ-10450232 250 mg	Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)	8.95 units on a scale	Standard Error 1.757
JNJ-10450232 1000 mg	Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)	20.56 units on a scale	Standard Error 1.797

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [11.42, 21.35]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.06895% CI: [-0.35, 9.51]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [11.21, 21.18]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-16.73, -6.88]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.94195% CI: [-5.17, 4.8]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (MEDIAN)
Placebo	Duration of Pain Relief After Dosing (Time to Rescue Medication)	109.0 minutes
Acetaminophen 1000 mg	Duration of Pain Relief After Dosing (Time to Rescue Medication)	468.5 minutes
JNJ-10450232 250 mg	Duration of Pain Relief After Dosing (Time to Rescue Medication)	129.0 minutes
JNJ-10450232 1000 mg	Duration of Pain Relief After Dosing (Time to Rescue Medication)	NA minutes

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects who withdrew from the study before 24 hours, but did not use rescue therapy, were censored at the time of discontinuation. Subjects who did not rescue medication during the 24-hour study period had their time to rescue set to 24 hours and were censored at 24 hours.p-value: 0.042Log Rank

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	1.08 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	1.60 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	1.57 units on a scale	Standard Error 0.36
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	3.87 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.30695% CI: [-0.48, 1.53]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.33595% CI: [-0.51, 1.49]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.78, 3.8]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.94695% CI: [-1.03, 0.97]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.25, 3.28]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose

Time frame: Baseline to 11 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	1.03 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	1.58 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	1.57 units on a scale	Standard Error 0.36
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	3.70 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.27995% CI: [-0.45, 1.56]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.29295% CI: [-0.46, 1.53]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.66, 3.68]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.97195% CI: [-1.02, 0.98]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.11, 3.12]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose

Time frame: Baseline to 12 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	1.08 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	1.57 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	1.39 units on a scale	Standard Error 0.35
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	3.61 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.32995% CI: [-0.5, 1.5]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.53195% CI: [-0.68, 1.31]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.53, 3.54]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.72295% CI: [-1.17, 0.81]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.03, 3.04]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose

Time frame: Baseline to 1.5 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	0.37 units on a scale	Standard Error 0.28
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	4.35 units on a scale	Standard Error 0.28
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	1.23 units on a scale	Standard Error 0.28
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	2.85 units on a scale	Standard Error 0.28

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [3.21, 4.77]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02895% CI: [0.09, 1.64]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.7, 3.26]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.9, -2.35]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.29, -0.73]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose

Time frame: Baseline to 15 minutes post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	0.13 units on a scale	Standard Error 0.11
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	0.25 units on a scale	Standard Error 0.11
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	0.06 units on a scale	Standard Error 0.11
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	0.21 units on a scale	Standard Error 0.11

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.44895% CI: [-0.19, 0.42]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.61895% CI: [-0.38, 0.22]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.62195% CI: [-0.23, 0.38]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.20795% CI: [-0.49, 0.11]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.79495% CI: [-0.34, 0.26]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose

Time frame: Baseline to 16 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	0.93 units on a scale	Standard Error 0.35
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	1.37 units on a scale	Standard Error 0.35
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	1.08 units on a scale	Standard Error 0.35
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	3.43 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.3895% CI: [-0.54, 1.42]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.76795% CI: [-0.83, 1.12]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.52, 3.49]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.55795% CI: [-1.27, 0.68]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.08, 3.05]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose

Time frame: Baseline to 1 hour post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	0.25 units on a scale	Standard Error 0.26
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	3.98 units on a scale	Standard Error 0.26
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	1.03 units on a scale	Standard Error 0.26
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	2.19 units on a scale	Standard Error 0.26

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [3.01, 4.46]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.03595% CI: [0.06, 1.49]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.21, 2.67]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.68, -2.24]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.52, -1.07]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose

Time frame: Baseline to 24 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	1.15 units on a scale	Standard Error 0.39
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	1.41 units on a scale	Standard Error 0.39
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	1.29 units on a scale	Standard Error 0.38
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	3.47 units on a scale	Standard Error 0.39

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.6495% CI: [-0.83, 1.35]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.79895% CI: [-0.94, 1.22]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.23, 3.42]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.82995% CI: [-1.2, 0.96]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.97, 3.16]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose

Time frame: Baseline to 2 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	0.41 units on a scale	Standard Error 0.31
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	4.20 units on a scale	Standard Error 0.31
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	1.43 units on a scale	Standard Error 0.31
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	3.48 units on a scale	Standard Error 0.31

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.92, 4.65]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02195% CI: [0.16, 1.88]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.19, 3.93]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.63, -1.91]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.10495% CI: [-1.59, 0.15]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose

Time frame: Baseline to 30 minutes post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	0.25 units on a scale	Standard Error 0.19
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	1.59 units on a scale	Standard Error 0.19
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	0.46 units on a scale	Standard Error 0.18
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	0.71 units on a scale	Standard Error 0.19

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.82, 1.86]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.4295% CI: [-0.3, 0.72]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.08395% CI: [-0.06, 0.97]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-1.64, -0.62]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-1.4, -0.37]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose

Time frame: Baseline to 3 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	0.71 units on a scale	Standard Error 0.34
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	3.84 units on a scale	Standard Error 0.34
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	1.69 units on a scale	Standard Error 0.34
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	3.86 units on a scale	Standard Error 0.34

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.18, 4.07]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.04195% CI: [0.04, 1.92]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.19, 4.09]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.09, -1.21]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.97395% CI: [-0.93, 0.97]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose

Time frame: Baseline to 45 minutes post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	0.28 units on a scale	Standard Error 0.24
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	3.22 units on a scale	Standard Error 0.24
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	0.91 units on a scale	Standard Error 0.23
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	1.51 units on a scale	Standard Error 0.24

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.28, 3.59]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.05895% CI: [-0.02, 1.29]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.57, 1.89]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.96, -1.65]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.37, -1.04]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose

Time frame: Baseline to 4 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	0.91 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	3.78 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	1.79 units on a scale	Standard Error 0.35
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	4.17 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.87, 3.87]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.07995% CI: [-0.1, 1.88]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.27, 4.27]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.98, -1]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.4495% CI: [-0.61, 1.4]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose

Time frame: Baseline to 5 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	1.01 units on a scale	Standard Error 0.37
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	3.56 units on a scale	Standard Error 0.37
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	1.82 units on a scale	Standard Error 0.36
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	4.14 units on a scale	Standard Error 0.37

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.52, 3.57]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.11895% CI: [-0.21, 1.83]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.1, 4.16]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.75, -0.71]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.26295% CI: [-0.44, 1.62]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose

Time frame: Baseline to 6 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	1.12 units on a scale	Standard Error 0.37
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	3.04 units on a scale	Standard Error 0.37
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	1.69 units on a scale	Standard Error 0.37
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	4.07 units on a scale	Standard Error 0.38

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.88, 2.96]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.27195% CI: [-0.45, 1.61]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.91, 3.99]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.01195% CI: [-2.37, -0.32]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.05295% CI: [-0.01, 2.07]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose

Time frame: Baseline to 7 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	1.13 units on a scale	Standard Error 0.37
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	2.38 units on a scale	Standard Error 0.37
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	1.66 units on a scale	Standard Error 0.37
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	3.94 units on a scale	Standard Error 0.38

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.01895% CI: [0.21, 2.29]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.3195% CI: [-0.5, 1.56]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.76, 3.85]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.17295% CI: [-1.75, 0.31]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00495% CI: [0.51, 2.6]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose

Time frame: Baseline to 8 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	1.15 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	1.99 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	1.51 units on a scale	Standard Error 0.35
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	4.00 units on a scale	Standard Error 0.36

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.10295% CI: [-0.17, 1.84]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.47995% CI: [-0.64, 1.35]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.85, 3.86]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.34595% CI: [-1.47, 0.52]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.01, 3.02]ANOVA

Secondary

Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose

Time frame: Baseline to 9 hours post dose

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	1.19 units on a scale	Standard Error 0.36
Acetaminophen 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	1.69 units on a scale	Standard Error 0.36
JNJ-10450232 250 mg	Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	1.73 units on a scale	Standard Error 0.36
JNJ-10450232 1000 mg	Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	3.91 units on a scale	Standard Error 0.37

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.33895% CI: [-0.52, 1.51]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.29995% CI: [-0.47, 1.54]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.7, 3.73]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.94295% CI: [-0.97, 1.04]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.21, 3.24]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 10 Hours Post Dose	2.28 units on a scale	Standard Error 0.46
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 10 Hours Post Dose	2.67 units on a scale	Standard Error 0.46
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 10 Hours Post Dose	2.81 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 10 Hours Post Dose	5.40 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.54195% CI: [-0.87, 1.66]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.40995% CI: [-0.73, 1.79]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.85, 4.39]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.83495% CI: [-1.12, 1.39]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.45, 4]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 11 Hours Post Dose	2.26 units on a scale	Standard Error 0.45
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 11 Hours Post Dose	2.63 units on a scale	Standard Error 0.45
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 11 Hours Post Dose	2.75 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 11 Hours Post Dose	5.25 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.57395% CI: [-0.9, 1.63]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.44895% CI: [-0.77, 1.74]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.71, 4.25]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.84895% CI: [-1.13, 1.38]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.35, 3.89]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 12 Hours Post Dose	2.34 units on a scale	Standard Error 0.46
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 12 Hours Post Dose	2.57 units on a scale	Standard Error 0.46
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 12 Hours Post Dose	2.53 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 12 Hours Post Dose	5.16 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.7295% CI: [-1.04, 1.5]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.76395% CI: [-1.07, 1.45]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.55, 4.09]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.95295% CI: [-1.3, 1.22]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.31, 3.86]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 1.5 Hours Post Dose	1.01 units on a scale	Standard Error 0.35
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 1.5 Hours Post Dose	5.88 units on a scale	Standard Error 0.35
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 1.5 Hours Post Dose	2.13 units on a scale	Standard Error 0.34
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 1.5 Hours Post Dose	3.97 units on a scale	Standard Error 0.35

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [3.9, 5.84]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02395% CI: [0.16, 2.09]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.98, 3.93]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-4.71, -2.78]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.89, -0.94]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 15 Minutes Post Dose	0.27 units on a scale	Standard Error 0.11
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 15 Minutes Post Dose	0.52 units on a scale	Standard Error 0.11
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 15 Minutes Post Dose	0.33 units on a scale	Standard Error 0.11
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 15 Minutes Post Dose	0.38 units on a scale	Standard Error 0.12

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.11795% CI: [-0.06, 0.57]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.68795% CI: [-0.25, 0.38]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.49795% CI: [-0.21, 0.43]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.23995% CI: [-0.51, 0.13]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.37695% CI: [-0.46, 0.18]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 16 Hours Post Dose	2.09 units on a scale	Standard Error 0.45
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 16 Hours Post Dose	2.23 units on a scale	Standard Error 0.45
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 16 Hours Post Dose	2.07 units on a scale	Standard Error 0.44
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 16 Hours Post Dose	4.96 units on a scale	Standard Error 0.45

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.82195% CI: [-1.1, 1.39]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.97895% CI: [-1.25, 1.22]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.63, 4.13]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.79995% CI: [-1.39, 1.07]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.49, 3.98]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 1 Hour Post Dose	0.84 units on a scale	Standard Error 0.33
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 1 Hour Post Dose	5.18 units on a scale	Standard Error 0.33
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 1 Hour Post Dose	1.68 units on a scale	Standard Error 0.32
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 1 Hour Post Dose	3.09 units on a scale	Standard Error 0.33

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3, -1.17]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [3.43, 5.25]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.06795% CI: [-0.06, 1.75]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.34, 3.17]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-4.4, -2.59]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 24 Hours Post Dose	2.44 units on a scale	Standard Error 0.49
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 24 Hours Post Dose	2.20 units on a scale	Standard Error 0.5
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 24 Hours Post Dose	2.33 units on a scale	Standard Error 0.49
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 24 Hours Post Dose	4.96 units on a scale	Standard Error 0.5

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.72695% CI: [-1.62, 1.13]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.86995% CI: [-1.48, 1.25]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.13, 3.9]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.85195% CI: [-1.24, 1.5]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.38, 4.15]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 2 Hours Post Dose	1.17 units on a scale	Standard Error 0.38
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 2 Hours Post Dose	5.88 units on a scale	Standard Error 0.38
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 2 Hours Post Dose	2.53 units on a scale	Standard Error 0.38
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 2 Hours Post Dose	4.90 units on a scale	Standard Error 0.39

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [3.64, 5.78]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.01295% CI: [0.3, 2.42]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.66, 4.81]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-4.41, -2.29]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.07495% CI: [-2.05, 0.09]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 30 Minutes Post Dose	0.60 units on a scale	Standard Error 0.23
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 30 Minutes Post Dose	2.38 units on a scale	Standard Error 0.23
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 30 Minutes Post Dose	0.90 units on a scale	Standard Error 0.23
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 30 Minutes Post Dose	1.03 units on a scale	Standard Error 0.23

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.14, 2.42]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.3595% CI: [-0.33, 0.94]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.18395% CI: [-0.21, 1.08]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-2.11, -0.84]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-1.98, -0.7]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 3 Hours Post Dose	1.59 units on a scale	Standard Error 0.42
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 3 Hours Post Dose	5.39 units on a scale	Standard Error 0.42
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 3 Hours Post Dose	2.90 units on a scale	Standard Error 0.41
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 3 Hours Post Dose	5.40 units on a scale	Standard Error 0.42

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.63, 4.97]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02695% CI: [0.16, 2.48]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.64, 4.99]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.64, -1.32]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.97895% CI: [-1.16, 1.19]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 45 Minutes Post Dose	0.64 units on a scale	Standard Error 0.3
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 45 Minutes Post Dose	4.42 units on a scale	Standard Error 0.3
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 45 Minutes Post Dose	1.52 units on a scale	Standard Error 0.3
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 45 Minutes Post Dose	2.11 units on a scale	Standard Error 0.3

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.94, 4.61]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.03795% CI: [0.05, 1.71]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.63, 2.3]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.73, -2.07]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.15, -1.47]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 4 Hours Post Dose	1.92 units on a scale	Standard Error 0.44
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 4 Hours Post Dose	5.31 units on a scale	Standard Error 0.44
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 4 Hours Post Dose	2.99 units on a scale	Standard Error 0.43
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 4 Hours Post Dose	5.83 units on a scale	Standard Error 0.44

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.18, 4.62]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.08195% CI: [-0.13, 2.28]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.69, 5.14]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-3.53, -1.11]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.40795% CI: [-0.71, 1.74]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 5 Hours Post Dose	2.17 units on a scale	Standard Error 0.45
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 5 Hours Post Dose	5.00 units on a scale	Standard Error 0.45
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 5 Hours Post Dose	3.05 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 5 Hours Post Dose	5.77 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.56, 4.1]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.1795% CI: [-0.38, 2.14]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.33, 4.87]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00295% CI: [-3.21, -0.69]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.23595% CI: [-0.5, 2.04]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 6 Hours Post Dose	2.32 units on a scale	Standard Error 0.46
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 6 Hours Post Dose	4.42 units on a scale	Standard Error 0.46
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 6 Hours Post Dose	2.92 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 6 Hours Post Dose	5.68 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00195% CI: [0.82, 3.39]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.35595% CI: [-0.68, 1.87]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [2.07, 4.65]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02195% CI: [-2.78, -0.23]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.05695% CI: [-0.03, 2.55]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 7 Hours Post Dose	2.41 units on a scale	Standard Error 0.46
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 7 Hours Post Dose	3.62 units on a scale	Standard Error 0.47
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 7 Hours Post Dose	2.80 units on a scale	Standard Error 0.46
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 7 Hours Post Dose	5.57 units on a scale	Standard Error 0.47

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.06795% CI: [-0.09, 2.5]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.54795% CI: [-0.89, 1.68]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.86, 4.46]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.21495% CI: [-2.1, 0.47]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.00395% CI: [0.66, 3.26]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 8 Hours Post Dose	2.41 units on a scale	Standard Error 0.45
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 8 Hours Post Dose	3.10 units on a scale	Standard Error 0.45
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 8 Hours Post Dose	2.63 units on a scale	Standard Error 0.44
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 8 Hours Post Dose	5.62 units on a scale	Standard Error 0.45

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.28195% CI: [-0.57, 1.95]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.72995% CI: [-1.03, 1.47]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.95, 4.47]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.45995% CI: [-1.72, 0.78]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.26, 3.78]ANOVA

Secondary

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

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Pain Relief (PAR) Scores at 9 Hours Post Dose	2.46 units on a scale	Standard Error 0.46
Acetaminophen 1000 mg	Pain Relief (PAR) Scores at 9 Hours Post Dose	2.73 units on a scale	Standard Error 0.46
JNJ-10450232 250 mg	Pain Relief (PAR) Scores at 9 Hours Post Dose	2.98 units on a scale	Standard Error 0.45
JNJ-10450232 1000 mg	Pain Relief (PAR) Scores at 9 Hours Post Dose	5.50 units on a scale	Standard Error 0.46

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.67495% CI: [-1, 1.55]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.41795% CI: [-0.74, 1.79]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.77, 4.33]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.69895% CI: [-1.02, 1.52]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.49, 4.05]ANOVA

Secondary

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).

Population: Analysis is based on the Intent-to-Treat (ITT) population, which included all subjects who were randomized.

Arm	Measure	Group	Value (NUMBER)
Placebo	Subject Global Evaluation	Very Good (3)	10.4 percentage of participants
Placebo	Subject Global Evaluation	Fair (1)	14.9 percentage of participants
Placebo	Subject Global Evaluation	Excellent (4)	0.0 percentage of participants
Placebo	Subject Global Evaluation	Good (2)	11.9 percentage of participants
Placebo	Subject Global Evaluation	Poor (0)	62.7 percentage of participants
Acetaminophen 1000 mg	Subject Global Evaluation	Good (2)	30.3 percentage of participants
Acetaminophen 1000 mg	Subject Global Evaluation	Very Good (3)	42.4 percentage of participants
Acetaminophen 1000 mg	Subject Global Evaluation	Excellent (4)	6.1 percentage of participants
Acetaminophen 1000 mg	Subject Global Evaluation	Fair (1)	9.1 percentage of participants
Acetaminophen 1000 mg	Subject Global Evaluation	Poor (0)	12.1 percentage of participants
JNJ-10450232 250 mg	Subject Global Evaluation	Good (2)	21.7 percentage of participants
JNJ-10450232 250 mg	Subject Global Evaluation	Poor (0)	55.1 percentage of participants
JNJ-10450232 250 mg	Subject Global Evaluation	Fair (1)	4.3 percentage of participants
JNJ-10450232 250 mg	Subject Global Evaluation	Very Good (3)	15.9 percentage of participants
JNJ-10450232 250 mg	Subject Global Evaluation	Excellent (4)	2.9 percentage of participants
JNJ-10450232 1000 mg	Subject Global Evaluation	Very Good (3)	30.3 percentage of participants
JNJ-10450232 1000 mg	Subject Global Evaluation	Fair (1)	6.1 percentage of participants
JNJ-10450232 1000 mg	Subject Global Evaluation	Poor (0)	28.8 percentage of participants
JNJ-10450232 1000 mg	Subject Global Evaluation	Good (2)	22.7 percentage of participants
JNJ-10450232 1000 mg	Subject Global Evaluation	Excellent (4)	12.1 percentage of participants

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [1.1, 1.9]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.07795% CI: [0, 0.8]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [0.8, 1.6]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.00195% CI: [-1.6, -0.7]ANOVA

Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.14895% CI: [-0.7, 0.1]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026

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

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Analgesic Efficacy From 0 to 6 Hours After the Dose Using the Time-weighted Sum of Pain Intensity Difference (SPID 0-6)

Duration of Pain Relief After Dosing (Time to Rescue Medication)

Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose

Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose

Pain Relief (PAR) Scores at 10 Hours Post Dose

Pain Relief (PAR) Scores at 11 Hours Post Dose

Pain Relief (PAR) Scores at 12 Hours Post Dose

Pain Relief (PAR) Scores at 1.5 Hours Post Dose

Pain Relief (PAR) Scores at 15 Minutes Post Dose

Pain Relief (PAR) Scores at 16 Hours Post Dose

Pain Relief (PAR) Scores at 1 Hour Post Dose

Pain Relief (PAR) Scores at 24 Hours Post Dose

Pain Relief (PAR) Scores at 2 Hours Post Dose

Pain Relief (PAR) Scores at 30 Minutes Post Dose

Pain Relief (PAR) Scores at 3 Hours Post Dose

Pain Relief (PAR) Scores at 45 Minutes Post Dose

Pain Relief (PAR) Scores at 4 Hours Post Dose

Pain Relief (PAR) Scores at 5 Hours Post Dose

Pain Relief (PAR) Scores at 6 Hours Post Dose

Pain Relief (PAR) Scores at 7 Hours Post Dose

Pain Relief (PAR) Scores at 8 Hours Post Dose

Pain Relief (PAR) Scores at 9 Hours Post Dose

Subject Global Evaluation