Trial Outcomes & Findings for A Dental Pain Study to Test the Effectiveness of a New Pain Reliever Medicine (NCT NCT02209181)

NCT ID: NCT02209181

Last Updated: 2017-02-03

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 269 participants
• Primary outcome timeframe: 6 Hours
• Results posted on: 2017-02-03

Participant Flow

Participant milestones

Measure	Placebo Three placebo capsules taken orally	Acetaminophen 1000 mg Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Study STARTED	67	67	69	66
Overall Study COMPLETED	66	66	68	66
Overall Study NOT COMPLETED	1	1	1	0

Reasons for withdrawal

Measure	Placebo Three placebo capsules taken orally	Acetaminophen 1000 mg Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Overall Study Adverse Event	1	0	1	0
Overall Study Withdrawal by Subject	0	1	0	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally	Total n=269 Participants Total of all reporting groups
Age, Continuous	19.2 years STANDARD_DEVIATION 2.69 • n=5 Participants	19.0 years STANDARD_DEVIATION 1.64 • n=7 Participants	19.0 years STANDARD_DEVIATION 2.13 • n=5 Participants	19.3 years STANDARD_DEVIATION 1.95 • n=4 Participants	19.1 years STANDARD_DEVIATION 2.13 • n=21 Participants
Gender Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Gender Male	67 Participants n=5 Participants	67 Participants n=7 Participants	69 Participants n=5 Participants	66 Participants n=4 Participants	269 Participants n=21 Participants
Region of Enrollment USA	67 participants n=5 Participants	67 participants n=7 Participants	69 participants n=5 Participants	66 participants n=4 Participants	269 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 Hours

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

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).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
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	20.75 units on a scale Standard Error 1.783	8.95 units on a scale Standard Error 1.757	20.56 units on a scale Standard Error 1.797

SECONDARY outcome

Timeframe: Baseline to 15 minutes post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 15 Minutes Post Dose	0.13 units on a scale Standard Error 0.11	0.25 units on a scale Standard Error 0.11	0.06 units on a scale Standard Error 0.11	0.21 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline to 30 minutes post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 30 Minutes Post Dose	0.25 units on a scale Standard Error 0.19	1.59 units on a scale Standard Error 0.19	0.46 units on a scale Standard Error 0.18	0.71 units on a scale Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline to 45 minutes post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 45 Minutes Post Dose	0.28 units on a scale Standard Error 0.24	3.22 units on a scale Standard Error 0.24	0.91 units on a scale Standard Error 0.23	1.51 units on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline to 1 hour post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 1 Hour Post Dose	0.25 units on a scale Standard Error 0.26	3.98 units on a scale Standard Error 0.26	1.03 units on a scale Standard Error 0.26	2.19 units on a scale Standard Error 0.26

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 1.5 Hours Post Dose	0.37 units on a scale Standard Error 0.28	4.35 units on a scale Standard Error 0.28	1.23 units on a scale Standard Error 0.28	2.85 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline to 2 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 2 Hours Post Dose	0.41 units on a scale Standard Error 0.31	4.20 units on a scale Standard Error 0.31	1.43 units on a scale Standard Error 0.31	3.48 units on a scale Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline to 3 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 3 Hours Post Dose	0.71 units on a scale Standard Error 0.34	3.84 units on a scale Standard Error 0.34	1.69 units on a scale Standard Error 0.34	3.86 units on a scale Standard Error 0.34

SECONDARY outcome

Timeframe: Baseline to 4 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 4 Hours Post Dose	0.91 units on a scale Standard Error 0.36	3.78 units on a scale Standard Error 0.36	1.79 units on a scale Standard Error 0.35	4.17 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 5 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 5 Hours Post Dose	1.01 units on a scale Standard Error 0.37	3.56 units on a scale Standard Error 0.37	1.82 units on a scale Standard Error 0.36	4.14 units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline to 6 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 6 Hours Post Dose	1.12 units on a scale Standard Error 0.37	3.04 units on a scale Standard Error 0.37	1.69 units on a scale Standard Error 0.37	4.07 units on a scale Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline to 7 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 7 Hours Post Dose	1.13 units on a scale Standard Error 0.37	2.38 units on a scale Standard Error 0.37	1.66 units on a scale Standard Error 0.37	3.94 units on a scale Standard Error 0.38

SECONDARY outcome

Timeframe: Baseline to 8 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 8 Hours Post Dose	1.15 units on a scale Standard Error 0.36	1.99 units on a scale Standard Error 0.36	1.51 units on a scale Standard Error 0.35	4.00 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 9 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 9 Hours Post Dose	1.19 units on a scale Standard Error 0.36	1.69 units on a scale Standard Error 0.36	1.73 units on a scale Standard Error 0.36	3.91 units on a scale Standard Error 0.37

SECONDARY outcome

Timeframe: Baseline to 10 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 10 Hours Post Dose	1.08 units on a scale Standard Error 0.36	1.60 units on a scale Standard Error 0.36	1.57 units on a scale Standard Error 0.36	3.87 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 11 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 11 Hours Post Dose	1.03 units on a scale Standard Error 0.36	1.58 units on a scale Standard Error 0.36	1.57 units on a scale Standard Error 0.36	3.70 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 12 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 12 Hours Post Dose	1.08 units on a scale Standard Error 0.36	1.57 units on a scale Standard Error 0.36	1.39 units on a scale Standard Error 0.35	3.61 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 16 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 16 Hours Post Dose	0.93 units on a scale Standard Error 0.35	1.37 units on a scale Standard Error 0.35	1.08 units on a scale Standard Error 0.35	3.43 units on a scale Standard Error 0.36

SECONDARY outcome

Timeframe: Baseline to 24 hours post dose

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

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Intensity Difference From Baseline (PID) Scores at 24 Hours Post Dose	1.15 units on a scale Standard Error 0.39	1.41 units on a scale Standard Error 0.39	1.29 units on a scale Standard Error 0.38	3.47 units on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: 15 minutes post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 15 Minutes Post Dose	0.27 units on a scale Standard Error 0.11	0.52 units on a scale Standard Error 0.11	0.33 units on a scale Standard Error 0.11	0.38 units on a scale Standard Error 0.12

SECONDARY outcome

Timeframe: 30 minutes post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 30 Minutes Post Dose	0.60 units on a scale Standard Error 0.23	2.38 units on a scale Standard Error 0.23	0.90 units on a scale Standard Error 0.23	1.03 units on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: 45 minutes post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 45 Minutes Post Dose	0.64 units on a scale Standard Error 0.30	4.42 units on a scale Standard Error 0.30	1.52 units on a scale Standard Error 0.30	2.11 units on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: 1 hour post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 1 Hour Post Dose	0.84 units on a scale Standard Error 0.33	5.18 units on a scale Standard Error 0.33	1.68 units on a scale Standard Error 0.32	3.09 units on a scale Standard Error 0.33

SECONDARY outcome

Timeframe: 1.5 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 1.5 Hours Post Dose	1.01 units on a scale Standard Error 0.35	5.88 units on a scale Standard Error 0.35	2.13 units on a scale Standard Error 0.34	3.97 units on a scale Standard Error 0.35

SECONDARY outcome

Timeframe: 2 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 2 Hours Post Dose	1.17 units on a scale Standard Error 0.38	5.88 units on a scale Standard Error 0.38	2.53 units on a scale Standard Error 0.38	4.90 units on a scale Standard Error 0.39

SECONDARY outcome

Timeframe: 3 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 3 Hours Post Dose	1.59 units on a scale Standard Error 0.42	5.39 units on a scale Standard Error 0.42	2.90 units on a scale Standard Error 0.41	5.40 units on a scale Standard Error 0.42

SECONDARY outcome

Timeframe: 4 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 4 Hours Post Dose	1.92 units on a scale Standard Error 0.44	5.31 units on a scale Standard Error 0.44	2.99 units on a scale Standard Error 0.43	5.83 units on a scale Standard Error 0.44

SECONDARY outcome

Timeframe: 5 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 5 Hours Post Dose	2.17 units on a scale Standard Error 0.45	5.00 units on a scale Standard Error 0.45	3.05 units on a scale Standard Error 0.45	5.77 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 6 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 6 Hours Post Dose	2.32 units on a scale Standard Error 0.46	4.42 units on a scale Standard Error 0.46	2.92 units on a scale Standard Error 0.45	5.68 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 7 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 7 Hours Post Dose	2.41 units on a scale Standard Error 0.46	3.62 units on a scale Standard Error 0.47	2.80 units on a scale Standard Error 0.46	5.57 units on a scale Standard Error 0.47

SECONDARY outcome

Timeframe: 8 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 8 Hours Post Dose	2.41 units on a scale Standard Error 0.45	3.10 units on a scale Standard Error 0.45	2.63 units on a scale Standard Error 0.44	5.62 units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: 9 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 9 Hours Post Dose	2.46 units on a scale Standard Error 0.46	2.73 units on a scale Standard Error 0.46	2.98 units on a scale Standard Error 0.45	5.50 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 10 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 10 Hours Post Dose	2.28 units on a scale Standard Error 0.46	2.67 units on a scale Standard Error 0.46	2.81 units on a scale Standard Error 0.45	5.40 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 11 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 11 Hours Post Dose	2.26 units on a scale Standard Error 0.45	2.63 units on a scale Standard Error 0.45	2.75 units on a scale Standard Error 0.45	5.25 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 12 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 12 Hours Post Dose	2.34 units on a scale Standard Error 0.46	2.57 units on a scale Standard Error 0.46	2.53 units on a scale Standard Error 0.45	5.16 units on a scale Standard Error 0.46

SECONDARY outcome

Timeframe: 16 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 16 Hours Post Dose	2.09 units on a scale Standard Error 0.45	2.23 units on a scale Standard Error 0.45	2.07 units on a scale Standard Error 0.44	4.96 units on a scale Standard Error 0.45

SECONDARY outcome

Timeframe: 24 hours post dose

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

Pain relief is the amount of pain relief on a scale of 1-10 (where 1=no relief and 10=complete relief).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Pain Relief (PAR) Scores at 24 Hours Post Dose	2.44 units on a scale Standard Error 0.49	2.20 units on a scale Standard Error 0.50	2.33 units on a scale Standard Error 0.49	4.96 units on a scale Standard Error 0.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Duration of Pain Relief After Dosing (Time to Rescue Medication)	109.0 minutes Interval 97.0 to 189.0	468.5 minutes Interval 370.0 to 607.0	129.0 minutes Interval 100.0 to 725.0	NA minutes Interval 768.0 to Median and upper limit of the confidence interval were not estimable since less than 50% of the subjects treated with JNJ-10450232 1000 mg used rescue medication.

SECONDARY outcome

Timeframe: 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.

How the subject would rate the study medication as a pain-reliever on a scale of 0-4 (where 0=poor and 4=excellent).

Outcome measures

Measure	Placebo n=67 Participants Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 Participants Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 Participants One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 Participants One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Subject Global Evaluation Poor (0)	62.7 percentage of participants	12.1 percentage of participants	55.1 percentage of participants	28.8 percentage of participants
Subject Global Evaluation Fair (1)	14.9 percentage of participants	9.1 percentage of participants	4.3 percentage of participants	6.1 percentage of participants
Subject Global Evaluation Good (2)	11.9 percentage of participants	30.3 percentage of participants	21.7 percentage of participants	22.7 percentage of participants
Subject Global Evaluation Very Good (3)	10.4 percentage of participants	42.4 percentage of participants	15.9 percentage of participants	30.3 percentage of participants
Subject Global Evaluation Excellent (4)	0.0 percentage of participants	6.1 percentage of participants	2.9 percentage of participants	12.1 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Acetaminophen 1000 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

JNJ-10450232 250 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

JNJ-10450232 1000 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=67 participants at risk Three placebo capsules taken orally	Acetaminophen 1000 mg n=67 participants at risk Two encapsulated 500 mg tablets and one placebo capsule taken orally	JNJ-10450232 250 mg n=69 participants at risk One JNJ-10450232 250 mg capsule and two placebo capsules taken orally	JNJ-10450232 1000 mg n=66 participants at risk One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
Investigations Blood Bilirubin Increased	4.5% 3/67 • Within 7 days after dental surgery, +30 days for serious adverse events. Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.	7.5% 5/67 • Within 7 days after dental surgery, +30 days for serious adverse events. Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.	4.3% 3/69 • Within 7 days after dental surgery, +30 days for serious adverse events. Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.	7.6% 5/66 • Within 7 days after dental surgery, +30 days for serious adverse events. Adverse events (AEs) were systematically collected during the study and during the adverse event follow-up telephone interview within 7 days after dental surgery. Serious AEs were reported through 30 days after product use. Spontaneously reported AEs collected outside of the regularly scheduled telephone interviews were also recorded. Any clinically important abnormalities or causally-related AEs events persisting were followed until resolution or until reaching a clinically stable endpoint.

Additional Information

Joseph Aquilina, MD, Senior Director, Clinical Research

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

Phone: (215) 273-8025

Email: JAquilin@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60