Trial Outcomes & Findings for Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain (NCT NCT03224403)

NCT ID: NCT03224403

Last Updated: 2021-04-15

Results Overview

Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 664 participants
• Primary outcome timeframe: within 4 hours
• Results posted on: 2021-04-15

Participant Flow

Participant milestones

Measure	Placebo Two placebo caplets taken orally	Test ACM 1000 mg Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Overall Study STARTED	59	249	232	124
Overall Study COMPLETED	59	249	232	124
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized, Double-Blind, Single-Dose, Efficacy and Safety Study of Test Acetaminophen Tablet in Postoperative Dental Pain

Baseline characteristics by cohort

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg n=232 Participants Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg n=124 Participants Two commercial ibuprofen 200 mg liquid-filled capsules taken orally	Total n=664 Participants Total of all reporting groups
Age, Continuous	18.3 years STANDARD_DEVIATION 1.91 • n=5 Participants	19.0 years STANDARD_DEVIATION 2.31 • n=7 Participants	18.9 years STANDARD_DEVIATION 2.17 • n=5 Participants	19.2 years STANDARD_DEVIATION 2.56 • n=4 Participants	18.9 years STANDARD_DEVIATION 2.28 • n=21 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	139 Participants n=7 Participants	124 Participants n=5 Participants	65 Participants n=4 Participants	362 Participants n=21 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	110 Participants n=7 Participants	108 Participants n=5 Participants	59 Participants n=4 Participants	302 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	229 Participants n=7 Participants	215 Participants n=5 Participants	108 Participants n=4 Participants	607 Participants n=21 Participants
Race (NIH/OMB) More than one race	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
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Region of Enrollment United States	59 Participants n=5 Participants	249 Participants n=7 Participants	232 Participants n=5 Participants	124 Participants n=4 Participants	664 Participants n=21 Participants

PRIMARY outcome

Timeframe: within 4 hours

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

Minutes until confirmed perceptible pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg n=232 Participants Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg n=124 Participants Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Time to Confirmed Perceptible Pain Relief	NA minutes Interval 4.9 to 240.0 The median time to confirmed perceptible pain relief was not estimable since fewer than 50% of the participants treated with Placebo obtained confirmed perceptible pain relief.	15.7 minutes Interval 2.2 to 240.0	20.2 minutes Interval 4.0 to 240.0	23.2 minutes Interval 2.5 to 240.0

SECONDARY outcome

Timeframe: Within 4 hours

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

Minutes until meaningful pain relief is achieved. Stopwatch is started after the participant takes the study medication. The participants are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg n=232 Participants Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg n=124 Participants Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Time to Meaningful Pain Relief	NA minutes Interval 14.7 to 240.0 The median time to meaningful pain relief was not estimable since fewer than 50% of the participants treated with this study medication obtained meaningful pain relief.	46.1 minutes Interval 8.7 to 240.0	44.2 minutes Interval 12.6 to 240.0	43.9 minutes Interval 16.7 to 240.0

SECONDARY outcome

Timeframe: by 30 minutes

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

Percentage of participants with confirmed perceptible relief by 30 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 30 Minutes	18.6 Percentage of Participants	75.1 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 29 minutes

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

Percentage of participants with confirmed perceptible relief by 29 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 29 Minutes	18.6 Percentage of Participants	73.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 28 minutes

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

Percentage of participants with confirmed perceptible relief by 28 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 28 Minutes	18.6 Percentage of Participants	70.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 27 minutes

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

Percentage of participants with confirmed perceptible relief by 27 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 27 Minutes	18.6 Percentage of Participants	70.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 26 minutes

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

Percentage of participants with confirmed perceptible relief by 26 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 26 Minutes	18.6 Percentage of Participants	69.9 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 25 minutes

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

Percentage of participants with confirmed perceptible relief by 25 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 25 Minutes	18.6 Percentage of Participants	69.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 24 minutes

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

Percentage of participants with confirmed perceptible relief by 24 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 24 Minutes	18.6 Percentage of Participants	67.5 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 23 minutes

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

Percentage of participants with confirmed perceptible relief by 23 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 23 Minutes	18.6 Percentage of Participants	66.3 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 22 minutes

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

Percentage of participants with confirmed perceptible relief by 22 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 22 Minutes	16.9 Percentage of Participants	62.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 21 minutes

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

Percentage of participants with confirmed perceptible relief by 21 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 21 Minutes	15.3 Percentage of Participants	60.2 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 20 minutes

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

Percentage of participants with confirmed perceptible relief by 20 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 20 Minutes	13.6 Percentage of Participants	58.2 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 19 minutes

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

Percentage of participants with confirmed perceptible relief by 19 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 19 Minutes	13.6 Percentage of Participants	56.2 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 18 minutes

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

Percentage of participants with confirmed perceptible relief by 18 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 18 Minutes	13.6 Percentage of Participants	55.0 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 17 minutes

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

Percentage of participants with confirmed perceptible relief by 17 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 17 Minutes	13.6 Percentage of Participants	53.8 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 16 minutes

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

Percentage of participants with confirmed perceptible relief by 16 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 16 Minutes	10.2 Percentage of Participants	52.2 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 15 minutes

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

Percentage of participants with confirmed perceptible relief by 15 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 15 Minutes	10.2 Percentage of Participants	41.4 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 14 minutes

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

Percentage of participants with confirmed perceptible relief by 14 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 14 Minutes	8.5 Percentage of Participants	31.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 13 minutes

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

Percentage of participants with confirmed perceptible relief by 13 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 13 Minutes	8.5 Percentage of Participants	25.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 12 minutes

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

Percentage of participants with confirmed perceptible relief by 12 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 12 Minutes	8.5 Percentage of Participants	21.7 Percentage of Participants	—	—

SECONDARY outcome

Timeframe: by 11 minutes

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

Percentage of participants with confirmed perceptible relief by 11 minutes. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. Test acetaminophen 1000 mg and placebo were compared on the percentage of subjects with confirmed perceptible relief starting at 30 minutes and testing successively earlier minutes (29, 28, etc) until the difference was no longer statistically significant. The earliest significant time was identified.

Outcome measures

Measure	Placebo n=59 Participants Two placebo caplets taken orally	Test ACM 1000 mg n=249 Participants Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg Two commercial acetaminophen 500 mg caplets taken orally	Commercial IBU 400 mg Two commercial ibuprofen 200 mg liquid-filled capsules taken orally
Percentage of Participants With Confirmed Perceptible Relief From 30 Minutes to Successively Earlier Minutes in One-minute Increments - 11 Minutes	8.5 Percentage of Participants	18.1 Percentage of Participants	—	—

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Test ACM 1000 mg

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Commercial ACM 1000 mg

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Commercial IBU 400 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=59 participants at risk Two placebo caplets taken orally	Test ACM 1000 mg n=249 participants at risk Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg n=232 participants at risk Two test acetaminophen 500 mg tablets taken orally	Commercial IBU 400 mg n=124 participants at risk Two commercial ibuprofen 400 mg liquid-filled capsules taken orally
Infections and infestations Pyelonephritis	1.7% 1/59 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.00% 0/249 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.00% 0/232 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.00% 0/124 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.
Pregnancy, puerperium and perinatal conditions Abortion Spontaneous	0.00% 0/59 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.40% 1/249 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.00% 0/232 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	0.00% 0/124 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.

Other adverse events

Measure	Placebo n=59 participants at risk Two placebo caplets taken orally	Test ACM 1000 mg n=249 participants at risk Two test acetaminophen 500 mg tablets taken orally	Commercial ACM 1000 mg n=232 participants at risk Two test acetaminophen 500 mg tablets taken orally	Commercial IBU 400 mg n=124 participants at risk Two commercial ibuprofen 400 mg liquid-filled capsules taken orally
Gastrointestinal disorders Nausea	11.9% 7/59 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	5.2% 13/249 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	6.0% 14/232 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	5.6% 7/124 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.
Gastrointestinal disorders Vomiting	11.9% 7/59 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	4.0% 10/249 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	4.7% 11/232 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.	3.2% 4/124 • Beginning with signing of the informed consent form and continuing within 7 days after dental surgery for non-serious adverse events, +30 days after the subject's last dose or exposure to the investigational product for serious adverse events. AEs were systematically collected during the study and at the follow-up telephone interview within 7 days after surgery along with spontaneously reported AEs. Any clinically important abnormalities or causally-related AEs persisting were followed until resolution or until reaching a clinically stable endpoint. SAEs required immediate notification to the Sponsor. Any SAE occurring after the reporting period was to be promptly reported if a causal relationship to study product was suspected.

Additional Information

Andrew Myers, MD

JNJWorldwide

Phone: (215) 273-8421 USA EST

Email: AMyers3@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60