Trial Outcomes & Findings for A Study of Acetaminophen for Post Surgical Dental Pain (NCT NCT04018612)
NCT ID: NCT04018612
Last Updated: 2022-03-29
Results Overview
Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Time weighted sum of pain intensity difference from 0 to 24 hours was reported. Pain Intensity (PI-NPRS) was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min). SPID24 was include all nominal timepoints from T0 to T24.25 hours. SPID is calculated as Σ\[T(i) -T(i-1)\] x \[(PID(i-1) + PID(i))/2\], where T(0)=0, T(i) is the scheduled time, and PID(i) is the pain intensity difference (PID) score at time i. Pain intensity differences were calculated with respect to Baseline. A baseline assessment is defined as the last non-missing result prior to administration of the first dose of study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours
Results posted on
2022-03-29
Participant Flow
Participants were recruited from April 2019 till July 2019 from the site
A total of 226 participants were screened from Day-30 to Day 0 before getting randomized
Participant milestones
| Measure |
High Dose APAP
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
22
|
|
Overall Study
COMPLETED
|
43
|
44
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
High Dose APAP
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
Baseline Characteristics
A Study of Acetaminophen for Post Surgical Dental Pain
Baseline characteristics by cohort
| Measure |
High Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.7 years
STANDARD_DEVIATION 2.06 • n=5 Participants
|
18.8 years
STANDARD_DEVIATION 2.31 • n=7 Participants
|
19.3 years
STANDARD_DEVIATION 2.42 • n=5 Participants
|
18.9 years
STANDARD_DEVIATION 2.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race-Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race-White
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race-Others
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race-Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race- Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity-Hispanic or Latino
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethinicity-Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Body Mass Index
|
24.45 kg/m^2
STANDARD_DEVIATION 4.124 • n=5 Participants
|
24.33 kg/m^2
STANDARD_DEVIATION 3.762 • n=7 Participants
|
25.49 kg/m^2
STANDARD_DEVIATION 4.869 • n=5 Participants
|
24.61 kg/m^2
STANDARD_DEVIATION 4.130 • n=4 Participants
|
|
Categorical pain intensity score
None (0)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Categorical pain intensity score
Mild (1)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Categorical pain intensity score
Moderate (2)
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Categorical pain intensity score
Severe (3)
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
NRS pain intensity
0 = No pain
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
NRS pain intensity
1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
NRS pain intensity
2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
NRS pain intensity
3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
NRS pain intensity
4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
NRS pain intensity
5
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
NRS pain intensity
6
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
NRS pain intensity
7
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
NRS pain intensity
8
|
13 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
NRS pain intensity
9
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
NRS pain intensity
10 = Worst imaginable pain
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Time weighted sum of pain intensity difference from 0 to 24 hours was reported. Pain Intensity (PI-NPRS) was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min). SPID24 was include all nominal timepoints from T0 to T24.25 hours. SPID is calculated as Σ\[T(i) -T(i-1)\] x \[(PID(i-1) + PID(i))/2\], where T(0)=0, T(i) is the scheduled time, and PID(i) is the pain intensity difference (PID) score at time i. Pain intensity differences were calculated with respect to Baseline. A baseline assessment is defined as the last non-missing result prior to administration of the first dose of study medication.
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Sum of Pain Intensity Difference From 0 to 24 Hours (SPID24) Based on the 11 Point Numeric Pain Rating Scale
|
-96.80 score on a scale
Standard Error 6.369
|
-100.69 score on a scale
Standard Error 6.333
|
-74.96 score on a scale
Standard Error 9.055
|
PRIMARY outcome
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Pain Relief Rating (PR) was scored on a 5-point scale (0=no-, 1=a little-, 2=some-, 3=a lot of-, and 4=complete- PR). PR was collected at initiation of Dose 1 (T0) and post dose 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 (± 10 min) hours. TOTPAR24 is calculated as Sum (\[T(i) - T(i-1)\] x (PR(i-1) + PR(i)) / 2), where T(0)=0, T(i) is the actual time, and PR(i) is the pain relief score at time i. and calculated as Σ\[T(i) -T(i-1)\] x \[(PR(i-1) + PR(i))/2\], where T(0)=0, T(i) is the scheduled time, and PR(i) is the pain relief (PR) score at time i.
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Sum of Pain Relief From 0 to 24 Hours (TOTPAR24) Based on a 5-point Likert Scale.
|
55.82 score on a scale
Standard Error 3.024
|
55.24 score on a scale
Standard Error 3.007
|
43.11 score on a scale
Standard Error 4.300
|
SECONDARY outcome
Timeframe: 0 to 24 HoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Upon initiation of the infusion of Dose 1, the participants were given stopwatch #1 and asked to press the stopwatch when they first perceived any pain relief (first perceptible pain relief \[FPR\]) ; a record of the time was noted in the participant record. If a participant does not record perceptible pain relief and prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
Median time to FPR-C (hours)- for moderate baseline categorical pain intensity score
|
0.215 hours
Interval 0.08 to 1.0
|
0.160 hours
Interval 0.03 to 0.43
|
0.595 hours
Interval 0.06 to 24.0
|
|
Time to Perceptible Pain Relief Confirmed (FPR-C) After Dose 1 Administration Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
Median time to FPR-C (hours)- for severe baseline categorical pain intensity score
|
0.160 hours
Interval 0.03 to 24.0
|
0.220 hours
Interval 0.06 to 24.0
|
0.890 hours
Interval 0.04 to 24.0
|
SECONDARY outcome
Timeframe: 0 to 24 HoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Upon initiation of the infusion of Dose 1, the participants were given a second stopwatch and asked to press the stopwatch if and when they feel any meaningful perceptible relief; a record of the time was noted in the participant record. If a participant does not record perceptible pain relief and was prematurely discontinued from the study prior to 24 hours, then the participant was censored at time of drop out. If a participant does not record perceptible pain relief prior to taking rescue medication, the participant was censored at 24 hours.
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
Median time to MPR (hours)- for moderate baseline categorical pain intensity score
|
0.660 hours
Interval 0.25 to 24.0
|
0.310 hours
Interval 0.11 to 24.0
|
NA hours
Median was not estimable as less than 50% of the participants obtained Meaningful Perceptible Relief by 24 hours
|
|
Time to Meaningful Perceptible Relief (MPR) Measure Stratified by Baseline Pain Score of Moderate or Severe for the 3 Treatment Groups
Median time to MPR (hours)- for severe baseline categorical pain intensity score
|
0.680 hours
Interval 0.12 to 24.0
|
0.870 hours
Interval 0.15 to 24.0
|
NA hours
Median was not estimable as less than 50% of the participants obtained Meaningful Perceptible Relief by 24 hours
|
SECONDARY outcome
Timeframe: 0 to 24 HoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Patients Global Evaluation was assessed on a scale of 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent) at 24.25 hours post-dose 1 or at participant withdrawal (if applicable), whichever occurred first. Least squares mean of the score are reported.
Outcome measures
| Measure |
High Dose APAP
n=42 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Patient Global Evaluation of the Study Medication
|
2.8 score on a scale
Standard Error 0.16
|
2.7 score on a scale
Standard Error 0.15
|
2.3 score on a scale
Standard Error 0.22
|
SECONDARY outcome
Timeframe: Baseline (0.0) and 0.5, 0.75, 1, 1.25, 1.75, 2.25 3.25, 4.25, 5.25, 6.25, 7.25, 8.25, 9.25, 10.25, 11.25, 12.25 (± 5 min) and 14.25, 16.25, 18.25, 20.25, 22.25, and 24.25 hours (± 10 min)Population: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Pain Intensity was self-reported over 24 hours, using a pain rating of 0-10 on the Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain). Pain intensity differences were calculated with respect to Baseline at each time point after Dose 1 administration. A baseline assessment was defined as the last non-missing result prior to administration of the first dose of study medication
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
16.25
|
-3.5 score on a scale
Standard Deviation 2.29
|
-4.4 score on a scale
Standard Deviation 2.08
|
-2.9 score on a scale
Standard Deviation 1.97
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
18.25
|
-4.4 score on a scale
Standard Deviation 2.34
|
-4.5 score on a scale
Standard Deviation 2.27
|
-3.5 score on a scale
Standard Deviation 1.97
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
20.25
|
-4.7 score on a scale
Standard Deviation 2.04
|
-4.9 score on a scale
Standard Deviation 2.37
|
-3.6 score on a scale
Standard Deviation 2.24
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
22.25
|
-4.7 score on a scale
Standard Deviation 2.25
|
-5.0 score on a scale
Standard Deviation 2.35
|
-3.9 score on a scale
Standard Deviation 2.19
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
24.25
|
-4.6 score on a scale
Standard Deviation 2.29
|
-5.1 score on a scale
Standard Deviation 2.42
|
-4.3 score on a scale
Standard Deviation 1.86
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
0.5
|
-2.5 score on a scale
Standard Deviation 1.65
|
-3.1 score on a scale
Standard Deviation 2.01
|
-0.7 score on a scale
Standard Deviation 1.28
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
0.75
|
-3.3 score on a scale
Standard Deviation 1.88
|
-3.5 score on a scale
Standard Deviation 2.10
|
-0.8 score on a scale
Standard Deviation 1.40
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
1
|
-3.7 score on a scale
Standard Deviation 1.89
|
-3.8 score on a scale
Standard Deviation 2.12
|
-0.8 score on a scale
Standard Deviation 1.44
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
1.25
|
-3.9 score on a scale
Standard Deviation 2.02
|
-4.0 score on a scale
Standard Deviation 2.29
|
-0.7 score on a scale
Standard Deviation 1.52
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
1.75
|
-3.9 score on a scale
Standard Deviation 1.97
|
-3.7 score on a scale
Standard Deviation 2.45
|
-0.7 score on a scale
Standard Deviation 1.59
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
2.25
|
-3.8 score on a scale
Standard Deviation 2.16
|
-3.6 score on a scale
Standard Deviation 2.44
|
-0.7 score on a scale
Standard Deviation 1.67
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
3.25
|
-3.4 score on a scale
Standard Deviation 2.32
|
-3.0 score on a scale
Standard Deviation 2.39
|
-0.9 score on a scale
Standard Deviation 1.95
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
4.25
|
-3.4 score on a scale
Standard Deviation 2.40
|
-2.9 score on a scale
Standard Deviation 2.32
|
-0.9 score on a scale
Standard Deviation 1.97
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
5.25
|
-3.3 score on a scale
Standard Deviation 2.48
|
-2.8 score on a scale
Standard Deviation 2.39
|
-2.4 score on a scale
Standard Deviation 2.59
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
6.25
|
-3.2 score on a scale
Standard Deviation 2.48
|
-3.5 score on a scale
Standard Deviation 2.49
|
-3.7 score on a scale
Standard Deviation 2.32
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
7.25
|
-3.0 score on a scale
Standard Deviation 2.61
|
-4.1 score on a scale
Standard Deviation 2.34
|
-4.2 score on a scale
Standard Deviation 1.99
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
8.25
|
-3.8 score on a scale
Standard Deviation 2.72
|
-4.4 score on a scale
Standard Deviation 2.29
|
-3.7 score on a scale
Standard Deviation 2.36
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
9.25
|
-4.5 score on a scale
Standard Deviation 2.89
|
-4.7 score on a scale
Standard Deviation 2.18
|
-3.6 score on a scale
Standard Deviation 2.26
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
10.25
|
-4.6 score on a scale
Standard Deviation 2.71
|
-5.0 score on a scale
Standard Deviation 1.98
|
-3.4 score on a scale
Standard Deviation 2.22
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
11.25
|
-4.7 score on a scale
Standard Deviation 2.44
|
-4.5 score on a scale
Standard Deviation 1.99
|
-3.3 score on a scale
Standard Deviation 2.28
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
12.25
|
-4.9 score on a scale
Standard Deviation 1.85
|
-4.5 score on a scale
Standard Deviation 2.31
|
-2.7 score on a scale
Standard Deviation 2.27
|
|
Pain Intensity Difference Rating (PID) at Different Timepoints After Dose 1 Administration
14.25
|
-3.7 score on a scale
Standard Deviation 2.13
|
-5.0 score on a scale
Standard Deviation 2.42
|
-2.9 score on a scale
Standard Deviation 1.97
|
SECONDARY outcome
Timeframe: 0 to 24 hoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Pain intensity is reported using the 11-point Numerical Rating Scale (NRS), with score between 0-10 (0= no pain; 10 = worst imaginable pain).
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
0.75
|
4.0 score on a scale
Standard Deviation 2.12
|
4.0 score on a scale
Standard Deviation 1.98
|
6.0 score on a scale
Standard Deviation 1.70
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
1
|
3.6 score on a scale
Standard Deviation 1.98
|
3.7 score on a scale
Standard Deviation 2.01
|
6.0 score on a scale
Standard Deviation 1.68
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
1.25
|
3.4 score on a scale
Standard Deviation 2.16
|
3.5 score on a scale
Standard Deviation 2.14
|
6.2 score on a scale
Standard Deviation 1.89
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
1.75
|
3.5 score on a scale
Standard Deviation 2.24
|
3.8 score on a scale
Standard Deviation 2.33
|
6.2 score on a scale
Standard Deviation 1.94
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
2.25
|
3.6 score on a scale
Standard Deviation 2.40
|
3.9 score on a scale
Standard Deviation 2.39
|
6.2 score on a scale
Standard Deviation 1.97
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
3.25
|
3.9 score on a scale
Standard Deviation 2.53
|
4.5 score on a scale
Standard Deviation 2.48
|
6.0 score on a scale
Standard Deviation 2.17
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
4.25
|
4.0 score on a scale
Standard Deviation 2.58
|
4.6 score on a scale
Standard Deviation 2.33
|
6.0 score on a scale
Standard Deviation 2.21
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
5.25
|
4.0 score on a scale
Standard Deviation 2.48
|
4.7 score on a scale
Standard Deviation 2.44
|
4.5 score on a scale
Standard Deviation 2.56
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
6.25
|
4.2 score on a scale
Standard Deviation 2.52
|
4.0 score on a scale
Standard Deviation 2.59
|
3.2 score on a scale
Standard Deviation 2.11
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
7.25
|
4.3 score on a scale
Standard Deviation 2.46
|
3.4 score on a scale
Standard Deviation 2.22
|
2.7 score on a scale
Standard Deviation 1.86
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
8.25
|
3.5 score on a scale
Standard Deviation 2.58
|
3.1 score on a scale
Standard Deviation 2.20
|
3.2 score on a scale
Standard Deviation 2.30
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
9.25
|
2.9 score on a scale
Standard Deviation 2.71
|
2.8 score on a scale
Standard Deviation 1.95
|
3.3 score on a scale
Standard Deviation 2.25
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
10.25
|
2.8 score on a scale
Standard Deviation 2.48
|
2.5 score on a scale
Standard Deviation 1.68
|
3.5 score on a scale
Standard Deviation 2.15
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
0.5
|
4.8 score on a scale
Standard Deviation 1.83
|
4.4 score on a scale
Standard Deviation 1.97
|
6.1 score on a scale
Standard Deviation 1.42
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
11.25
|
2.7 score on a scale
Standard Deviation 2.27
|
3.0 score on a scale
Standard Deviation 1.66
|
3.5 score on a scale
Standard Deviation 2.24
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
12.25
|
2.5 score on a scale
Standard Deviation 1.83
|
3.0 score on a scale
Standard Deviation 2.09
|
4.1 score on a scale
Standard Deviation 2.32
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
14.25
|
3.6 score on a scale
Standard Deviation 2.29
|
2.5 score on a scale
Standard Deviation 2.11
|
4.0 score on a scale
Standard Deviation 2.08
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
16.25
|
3.8 score on a scale
Standard Deviation 2.55
|
3.1 score on a scale
Standard Deviation 2.01
|
4.0 score on a scale
Standard Deviation 2.21
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
18.25
|
2.9 score on a scale
Standard Deviation 2.58
|
3.0 score on a scale
Standard Deviation 2.23
|
3.4 score on a scale
Standard Deviation 1.99
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
20.25
|
2.7 score on a scale
Standard Deviation 2.28
|
2.6 score on a scale
Standard Deviation 2.14
|
3.2 score on a scale
Standard Deviation 2.22
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
22.25
|
2.6 score on a scale
Standard Deviation 2.58
|
2.5 score on a scale
Standard Deviation 1.96
|
3.0 score on a scale
Standard Deviation 2.16
|
|
Pain Intensity Rating at Different Timepoints After Dose 1 Administration
24.25
|
2.8 score on a scale
Standard Deviation 2.38
|
2.4 score on a scale
Standard Deviation 2.06
|
2.61 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: 0 to 24 hoursPopulation: The Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Pain Relief is reported on a 5-Point Categorical Pain Relief Assessment scale: 0 = No Pain Relief, 1 = A Little Pain Relief, 2 = Some Pain Relief, 3 = A Lot of Pain Relief, 4 = Complete Pain Relief.
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
0.5
|
1.7 score on a scale
Standard Deviation 0.95
|
1.8 score on a scale
Standard Deviation 0.94
|
0.6 score on a scale
Standard Deviation 0.85
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
0.75
|
2.0 score on a scale
Standard Deviation 1.02
|
2.0 score on a scale
Standard Deviation 0.98
|
0.6 score on a scale
Standard Deviation 0.85
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
1
|
2.1 score on a scale
Standard Deviation 0.93
|
2.2 score on a scale
Standard Deviation 0.96
|
0.6 score on a scale
Standard Deviation 0.85
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
1.25
|
2.3 score on a scale
Standard Deviation 0.97
|
2.2 score on a scale
Standard Deviation 0.99
|
0.6 score on a scale
Standard Deviation 0.85
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
1.75
|
2.3 score on a scale
Standard Deviation 0.97
|
2.0 score on a scale
Standard Deviation 1.07
|
0.6 score on a scale
Standard Deviation 0.90
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
2.25
|
2.2 score on a scale
Standard Deviation 1.09
|
2.0 score on a scale
Standard Deviation 1.05
|
0.6 score on a scale
Standard Deviation 0.90
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
3.25
|
2.0 score on a scale
Standard Deviation 1.18
|
1.7 score on a scale
Standard Deviation 1.12
|
0.8 score on a scale
Standard Deviation 1.15
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
4.25
|
2.0 score on a scale
Standard Deviation 1.21
|
1.6 score on a scale
Standard Deviation 1.12
|
0.7 score on a scale
Standard Deviation 1.08
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
5.25
|
1.9 score on a scale
Standard Deviation 1.20
|
1.5 score on a scale
Standard Deviation 1.21
|
1.5 score on a scale
Standard Deviation 1.44
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
6.25
|
1.9 score on a scale
Standard Deviation 1.23
|
1.9 score on a scale
Standard Deviation 1.15
|
2.1 score on a scale
Standard Deviation 1.25
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
7.25
|
1.8 score on a scale
Standard Deviation 1.21
|
2.2 score on a scale
Standard Deviation 1.03
|
2.5 score on a scale
Standard Deviation 1.10
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
8.25
|
2.2 score on a scale
Standard Deviation 1.15
|
2.4 score on a scale
Standard Deviation 1.06
|
2.2 score on a scale
Standard Deviation 1.27
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
9.25
|
2.6 score on a scale
Standard Deviation 1.22
|
2.5 score on a scale
Standard Deviation 0.93
|
2.1 score on a scale
Standard Deviation 1.19
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
10.25
|
2.6 score on a scale
Standard Deviation 1.10
|
2.7 score on a scale
Standard Deviation 0.80
|
2.0 score on a scale
Standard Deviation 1.20
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
11.25
|
2.7 score on a scale
Standard Deviation 0.97
|
2.5 score on a scale
Standard Deviation 0.87
|
2.0 score on a scale
Standard Deviation 1.31
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
12.25
|
2.7 score on a scale
Standard Deviation 0.83
|
2.4 score on a scale
Standard Deviation 1.04
|
1.6 score on a scale
Standard Deviation 1.33
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
14.25
|
2.1 score on a scale
Standard Deviation 1.00
|
2.6 score on a scale
Standard Deviation 1.04
|
1.8 score on a scale
Standard Deviation 1.11
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
16.25
|
2.1 score on a scale
Standard Deviation 1.14
|
2.3 score on a scale
Standard Deviation 1.06
|
1.8 score on a scale
Standard Deviation 1.14
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
18.25
|
2.5 score on a scale
Standard Deviation 1.10
|
2.4 score on a scale
Standard Deviation 1.02
|
2.1 score on a scale
Standard Deviation 1.17
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
20.25
|
2.7 score on a scale
Standard Deviation 1.00
|
2.6 score on a scale
Standard Deviation 0.95
|
2.2 score on a scale
Standard Deviation 1.18
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
22.25
|
2.7 score on a scale
Standard Deviation 1.11
|
2.6 score on a scale
Standard Deviation 0.94
|
2.3 score on a scale
Standard Deviation 1.09
|
|
Pain Relief (PR) Ratings at Each Observation Time After Dose 1 Administration
24.25
|
2.5 score on a scale
Standard Deviation 1.12
|
2.7 score on a scale
Standard Deviation 0.99
|
2.5 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 0 to 24 HoursPopulation: The Evaluable Population included all randomized participant who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1.
Time to treatment failure is defined as time to first dose of rescue medication after Dose 1 or withdrawal from the study for any reason. If a participant does not take rescue medication or withdraw from the study prior to 24 hours, the participant was censored at 24 hours
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Time to Treatment Failure
Median time to treatment failure- for moderate baseline categorical pain intensity score
|
NA hours
Median was not estimable as less than 50% of the participants had treatment failure by 24 hours
|
NA hours
Median was not estimable as less than 50% of the participants had treatment failure by 24 hours
|
3.680 hours
Interval 1.1 to 24.0
|
|
Time to Treatment Failure
Median time to treatment failure for severe baseline categorical pain intensity score
|
NA hours
Median was not estimable as less than 50% of the participants had treatment failure by 24 hours
|
NA hours
Median was not estimable as less than 50% of the participants had treatment failure by 24 hours
|
1.335 hours
Interval 1.03 to 24.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hoursPopulation: The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries.
Change from Baseline in systolic blood pressure is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Systolic blood pressure is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min).
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Mean Change From Baseline to 24 Hours in Vital Signs (Systolic Blood Pressure)
|
1.6 mm Hg
Standard Deviation 10.78
|
1.0 mm Hg
Standard Deviation 11.39
|
9.2 mm Hg
Standard Deviation 10.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hoursPopulation: The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries.
Change from Baseline in diastolic blood pressure is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Diastolic blood pressure is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min)
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Mean Change From Baseline to 24 Hours in Vital Signs (Diastolic Blood Pressure)
|
-0.2 mm Hg
Standard Deviation 8.82
|
2.3 mm Hg
Standard Deviation 9.56
|
5.2 mm Hg
Standard Deviation 11.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hoursPopulation: The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries.
Change from Baseline in temperature is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Temperature is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min)
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Mean Change From Baseline to 24 Hours in Vital Signs (Temperature)
|
0.12 degrees Celsius
Standard Deviation 0.336
|
0.21 degrees Celsius
Standard Deviation 0.275
|
0.06 degrees Celsius
Standard Deviation 0.347
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hoursPopulation: The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries.
Change from Baseline in pulse rate is the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Pulse rate is obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min)
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Mean Change From Baseline to 24 Hours in Vital Signs (Pulse Rate)
|
5.0 beats/minute
Standard Deviation 11.85
|
4.2 beats/minute
Standard Deviation 11.58
|
5.7 beats/minute
Standard Deviation 11.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 24 hoursPopulation: The Safety Population included all randomized participants who received the study medication. This population was used for all safety summaries.
Change from Baseline in respiratory rate was the value at 24 hours minus value at Baseline. Baseline was defined as the last non-missing result prior to administration of the first dose of study drug. Respiratory rate was obtained at screening, prior to surgery and at Hours 4, 8, 12, 16, 20 and 24 following initiation of dose (±10 min)
Outcome measures
| Measure |
High Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=21 Participants
Placebo given post-operatively
|
|---|---|---|---|
|
Mean Change From Baseline to 24 Hours in Vital Signs (Respiratory Rate)
|
0.3 breaths/minute
Standard Deviation 3.39
|
-0.6 breaths/minute
Standard Deviation 4.12
|
-1.3 breaths/minute
Standard Deviation 3.68
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dosePopulation: The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters.
The Area Under the Plasma Concentration-Time Curve (AUC) is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. The values for pharmacokinetic (PK) evaluable population-excluding participants with positive pre-dose concentrations have been populated. The samples were collected at 5 min prior to Dose 1, and at 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose 1.
Outcome measures
| Measure |
High Dose APAP
n=31 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=38 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time of Administration to 24 Hours After Dosing (AUC 0-24h)
|
236326.3081 microgram*hour/milliliter
Standard Error 1.06026
|
231104.0073 microgram*hour/milliliter
Standard Error 1.05427
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dosePopulation: The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters
The AUC(0-infinity) is area under the plasma concentration-time curve from time zero to infinite time. The samples were collected at 5 min prior to Dose 1, and at 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dose 1.
Outcome measures
| Measure |
High Dose APAP
n=42 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
|
75925.2553 hour*nanogram per milliliter
Geometric Coefficient of Variation 22.405
|
55018.1382 hour*nanogram per milliliter
Geometric Coefficient of Variation 27.089
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dosePopulation: The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters
The half-life (t 1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration.
Outcome measures
| Measure |
High Dose APAP
n=42 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=43 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Half-life
|
2.565 hours
Standard Deviation 0.5774
|
2.360 hours
Standard Deviation 0.4134
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1.0, 2.0, 4.0, 6.25, 8.0, 8.25, 8.25, 12.0, 12.25, 16.0, 16.25, 18.0, 18.25, 24.25 hours post-dosePopulation: The PK Evaluable Population included all randomized participants who, as documented prior to the breaking of the study blind: (1) met all the inclusion and exclusion criteria and; (2) were administered Dose 1 resulting in an adequate number of quantifiable concentrations to calculate PK parameters
The Plasma Concentration (Cmax) is defined as maximum observed concentration
Outcome measures
| Measure |
High Dose APAP
n=31 Participants
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=39 Participants
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
Placebo given post-operatively
|
|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
|
39531.4 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 26
|
28495.6 nanogram per milliliter (ng/ml)
Geometric Coefficient of Variation 30
|
—
|
Adverse Events
High Dose APAP
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Low Dose APAP
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Dose APAP
n=44 participants at risk
Acetaminophen (APAP) administered post-operatively at a high dose
|
Low Dose APAP
n=44 participants at risk
Acetaminophen (APAP) administered post-operatively at a low dose
|
Placebo
n=22 participants at risk
Placebo given post-operatively
|
|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
4.5%
1/22 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
General disorders
Infusion site extravasation
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
General disorders
Infusion site haematoma
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
15.9%
7/44 • Number of events 7 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
18.2%
8/44 • Number of events 8 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
27.3%
6/22 • Number of events 6 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
4.5%
1/22 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Nervous system disorders
Headache
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
4.5%
1/22 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/44 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
2.3%
1/44 • Number of events 1 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
0.00%
0/22 • Up to 7 days (± 2 days)
An adverse event (AE) is defined as any untoward medical occurrence and does not necessarily have to have causal relationship with the study medication. An AE can therefore be an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease, which is a change from baseline and is temporally associated with the use of the study medication, whether or not it is considered related to the study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place