Trial Outcomes & Findings for Study of Long-Acting Acetaminophen in Postoperative Dental Pain (NCT NCT01960114)

NCT ID: NCT01960114

Last Updated: 2015-07-10

Results Overview

Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 403 participants
• Primary outcome timeframe: 10 Hours
• Results posted on: 2015-07-10

Participant Flow

Participant milestones

Measure	Placebo Placebo (two matching placebo tablets)	ACE ER 1500 mg Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Overall Study STARTED	134	269
Overall Study COMPLETED	133	268
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Placebo Placebo (two matching placebo tablets)	ACE ER 1500 mg Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Overall Study Adverse Event	1	0
Overall Study Could not swallow study medication	0	1

Baseline Characteristics

Study of Long-Acting Acetaminophen in Postoperative Dental Pain

Baseline characteristics by cohort

Measure	Placebo n=134 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=269 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)	Total n=403 Participants Total of all reporting groups
Age, Continuous	19.6 years STANDARD_DEVIATION 2.66 • n=5 Participants	19.5 years STANDARD_DEVIATION 2.82 • n=7 Participants	19.6 years STANDARD_DEVIATION 2.77 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	143 Participants n=7 Participants	215 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	126 Participants n=7 Participants	188 Participants n=5 Participants
Region of Enrollment USA	134 participants n=5 Participants	269 participants n=7 Participants	403 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 Hours

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

Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h.

Outcome measures

Measure	Placebo n=134 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=269 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10)	5.745 units on a scale Standard Error 2.5056	30.986 units on a scale Standard Error 1.8951

SECONDARY outcome

Timeframe: Within 12 Hours

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

Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief.

Outcome measures

Measure	Placebo n=134 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=268 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Time to Confirmed First Perceptible Pain Relief	NA Minutes Data for the placebo group are not available. Median and 95% Confidence Interval were not estimable because fewer than 50% of the subjects treated with Placebo obtained perceptible pain relief.	26.817 Minutes Interval 23.683 to 29.95

SECONDARY outcome

Timeframe: Within 12 Hours

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

Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.

Outcome measures

Measure	Placebo n=134 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=268 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Time to Meaningful Pain Relief	NA Minutes Data for the placebo group are not available. Median and 95% Confidence Interval were not estimable because fewer than 50% of the subjects treated with Placebo obtained meaningful pain relief.	84.675 Minutes Interval 66.333 to 120.633

SECONDARY outcome

Timeframe: Within 12 Hours

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

Minutes until rescue medication was given.

Outcome measures

Measure	Placebo n=134 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=268 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Duration of Pain Relief	106.5 Minutes Interval 99.0 to 132.0	NA Minutes Data for the acetaminophen ER 1500 mg group are not available. Median and 95% Confidence Interval were not estimable since fewer than 50% of the subjects treated with acetaminophen ER 1500 mg rescued.

SECONDARY outcome

Timeframe: 12 Hours

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

Patient Assessment of the pain medication - Number of subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent.

Outcome measures

Measure	Placebo n=133 Participants Placebo (two matching placebo tablets)	ACE ER 1500 mg n=268 Participants Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Patient Global Evaluation Poor (0)	63.2 percentage of participants	18.3 percentage of participants
Patient Global Evaluation Fair (1)	9.0 percentage of participants	11.2 percentage of participants
Patient Global Evaluation Good (2)	8.3 percentage of participants	14.6 percentage of participants
Patient Global Evaluation Very Good (3)	12.8 percentage of participants	35.8 percentage of participants
Patient Global Evaluation Excellent (4)	6.8 percentage of participants	20.1 percentage of participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

ACE ER 1500 mg

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Placebo n=134 participants at risk Placebo (two matching placebo tablets)	ACE ER 1500 mg n=268 participants at risk Acetaminophen ER 1500 mg (two 750 mg ER tablets)
Gastrointestinal disorders Nausea	10.4% 14/134 • Day 5-7 for non-serious adverse events, until 30 days after the last study site visit for serious adverse events. Adverse events were systematically collected at each study visit through the Follow Up Telephone Call (Day 5-7). Serious adverse events were reported through 30 days after the participant's last study site visit. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.	9.7% 26/268 • Day 5-7 for non-serious adverse events, until 30 days after the last study site visit for serious adverse events. Adverse events were systematically collected at each study visit through the Follow Up Telephone Call (Day 5-7). Serious adverse events were reported through 30 days after the participant's last study site visit. Spontaneously reported adverse events collected outside of the regularly scheduled visits were also recorded.

Additional Information

Rajesh Mishra, MD, PhD/Vice President, Medical/Clinical Affairs, Global OTC

McNeil Consumer Healthcare

Phone: 215-273-8569 USA EST

Email: rmishr16@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60