Trial Outcomes & Findings for To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery (NCT NCT01115673)
NCT ID: NCT01115673
Last Updated: 2012-05-28
Results Overview
Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
COMPLETED
PHASE3
540 participants
6 Hours
2012-05-28
Participant Flow
Participant milestones
| Measure |
ACE-1000
1000 mg Acetaminophen Caplet
|
ACE-650
650 mg Acetaminophen Caplet
|
ACE-0
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Overall Study
STARTED
|
239
|
241
|
60
|
|
Overall Study
COMPLETED
|
239
|
241
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
Baseline characteristics by cohort
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
Total
n=540 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
18.5 years
STANDARD_DEVIATION 2.24 • n=5 Participants
|
18.3 years
STANDARD_DEVIATION 1.96 • n=7 Participants
|
18.1 years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
18.4 years
STANDARD_DEVIATION 2.09 • n=4 Participants
|
|
Sex: Female, Male
Female
|
131 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
282 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
239 participants
n=5 Participants
|
241 participants
n=7 Participants
|
60 participants
n=5 Participants
|
540 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
|
529.4 units on a scale
Standard Error 22.31
|
427.3 units on a scale
Standard Error 22.21
|
60.0 units on a scale
Standard Error 44.51
|
SECONDARY outcome
Timeframe: 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain. The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference Over Six Hours (SPID6)
|
222.5 units on a scale
Standard Error 10.49
|
174.3 units on a scale
Standard Error 10.44
|
-4.2 units on a scale
Standard Error 20.93
|
SECONDARY outcome
Timeframe: 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief. The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
|
306.9 units on a scale
Standard Error 12.02
|
253.0 units on a scale
Standard Error 11.96
|
64.3 units on a scale
Standard Error 23.98
|
SECONDARY outcome
Timeframe: 15 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 15 Minutes
|
5.6 units on a scale
Standard Error 0.92
|
6.9 units on a scale
Standard Error 0.91
|
1.3 units on a scale
Standard Error 1.83
|
SECONDARY outcome
Timeframe: 30 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 30 Minutes
|
21.3 units on a scale
Standard Error 1.48
|
21.5 units on a scale
Standard Error 1.47
|
0.5 units on a scale
Standard Error 2.95
|
SECONDARY outcome
Timeframe: 45 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 45 Minutes
|
33.9 units on a scale
Standard Error 1.71
|
32.8 units on a scale
Standard Error 1.71
|
0.2 units on a scale
Standard Error 3.42
|
SECONDARY outcome
Timeframe: 60 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 60 Minutes
|
40.4 units on a scale
Standard Error 1.82
|
36.6 units on a scale
Standard Error 1.81
|
-0.1 units on a scale
Standard Error 3.62
|
SECONDARY outcome
Timeframe: 75 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 75 Minutes
|
43.1 units on a scale
Standard Error 1.88
|
37.6 units on a scale
Standard Error 1.87
|
-0.9 units on a scale
Standard Error 3.74
|
SECONDARY outcome
Timeframe: 90 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 90 Minutes
|
44.4 units on a scale
Standard Error 1.93 • Interval 1.92 to 3.85
|
38.0 units on a scale
Standard Error 1.92
|
-0.6 units on a scale
Standard Error 3.85
|
SECONDARY outcome
Timeframe: 120 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 120 Minutes
|
44.8 units on a scale
Standard Error 2.00
|
35.7 units on a scale
Standard Error 1.99
|
-2.7 units on a scale
Standard Error 3.99
|
SECONDARY outcome
Timeframe: 180 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 180 Minutes
|
40.8 units on a scale
Standard Error 2.03
|
31.9 units on a scale
Standard Error 2.02
|
-2.6 units on a scale
Standard Error 4.05
|
SECONDARY outcome
Timeframe: 240 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 240 Minutes
|
40.8 units on a scale
Standard Error 2.11
|
30.3 units on a scale
Standard Error 2.10
|
-1.1 units on a scale
Standard Error 4.20
|
SECONDARY outcome
Timeframe: 300 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, and did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 300 Minutes
|
37.9 units on a scale
Standard Error 2.17
|
27.1 units on a scale
Standard Error 2.16
|
-0.1 units on a scale
Standard Error 4.32
|
SECONDARY outcome
Timeframe: 360 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100. The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Intensity Difference (PID) at 360 Minutes
|
33.4 units on a scale
Standard Error 2.19
|
23.8 units on a scale
Standard Error 2.18
|
1.0 units on a scale
Standard Error 4.37
|
SECONDARY outcome
Timeframe: 15 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 15 Minutes
|
8.3 units on a scale
Standard Error 1.09
|
9.4 units on a scale
Standard Error 1.09
|
3.0 units on a scale
Standard Error 2.18
|
SECONDARY outcome
Timeframe: 30 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 30 Minutes
|
29.6 units on a scale
Standard Error 1.84
|
29.9 units on a scale
Standard Error 1.83
|
4.8 units on a scale
Standard Error 3.66
|
SECONDARY outcome
Timeframe: 45 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 45 Minutes
|
46.1 units on a scale
Standard Error 2.10
|
44.8 units on a scale
Standard Error 2.09
|
7.9 units on a scale
Standard Error 4.18
|
SECONDARY outcome
Timeframe: 60 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 60 Minutes
|
54.4 units on a scale
Standard Error 2.16
|
50.1 units on a scale
Standard Error 2.15
|
8.3 units on a scale
Standard Error 4.30
|
SECONDARY outcome
Timeframe: 75 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 75 Minutes
|
58.0 units on a scale
Standard Error 2.18
|
52.0 units on a scale
Standard Error 2.17
|
8.4 units on a scale
Standard Error 4.35
|
SECONDARY outcome
Timeframe: 90 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 90 Minutes
|
59.9 units on a scale
Standard Error 2.22
|
53.1 units on a scale
Standard Error 2.21
|
10.1 units on a scale
Standard Error 4.43
|
SECONDARY outcome
Timeframe: 120 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 120 Minutes
|
60.3 units on a scale
Standard Error 2.25
|
50.8 units on a scale
Standard Error 2.24
|
8.0 units on a scale
Standard Error 4.49
|
SECONDARY outcome
Timeframe: 180 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 180 Minutes
|
56.3 units on a scale
Standard Error 2.31
|
46.3 units on a scale
Standard Error 2.30
|
9.5 units on a scale
Standard Error 4.61
|
SECONDARY outcome
Timeframe: 240 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 240 Minutes
|
56.2 units on a scale
Standard Error 2.41
|
44.3 units on a scale
Standard Error 2.40
|
12.3 units on a scale
Standard Error 4.81
|
SECONDARY outcome
Timeframe: 300 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 300 Minutes
|
52.2 units on a scale
Standard Error 2.49
|
40.5 units on a scale
Standard Error 2.48
|
13.8 units on a scale
Standard Error 4.97
|
SECONDARY outcome
Timeframe: 360 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Pain Relief (PAR) Scores at 360 Minutes
|
48.0 units on a scale
Standard Error 2.51
|
36.6 units on a scale
Standard Error 2.50
|
14.0 units on a scale
Standard Error 5.02
|
SECONDARY outcome
Timeframe: 15 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
|
13.9 units on a scale
Standard Error 1.95
|
16.4 units on a scale
Standard Error 1.94
|
4.2 units on a scale
Standard Error 3.89
|
SECONDARY outcome
Timeframe: 30 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
|
50.9 units on a scale
Standard Error 3.26
|
51.3 units on a scale
Standard Error 3.24
|
5.2 units on a scale
Standard Error 6.50
|
SECONDARY outcome
Timeframe: 45 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
|
80.0 units on a scale
Standard Error 3.76
|
77.6 units on a scale
Standard Error 3.74
|
8.1 units on a scale
Standard Error 7.49
|
SECONDARY outcome
Timeframe: 60 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
|
94.9 units on a scale
Standard Error 3.92
|
86.7 units on a scale
Standard Error 3.90
|
8.2 units on a scale
Standard Error 7.81
|
SECONDARY outcome
Timeframe: 75 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
|
101.1 units on a scale
Standard Error 4.00
|
89.6 units on a scale
Standard Error 3.99
|
7.4 units on a scale
Standard Error 7.99
|
SECONDARY outcome
Timeframe: 90 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
|
104.2 units on a scale
Standard Error 4.10
|
91.2 units on a scale
Standard Error 4.08
|
9.4 units on a scale
Standard Error 8.18
|
SECONDARY outcome
Timeframe: 120 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
|
105.1 units on a scale
Standard Error 4.20
|
86.5 units on a scale
Standard Error 4.18
|
5.3 units on a scale
Standard Error 8.38
|
SECONDARY outcome
Timeframe: 180 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
|
97.1 units on a scale
Standard Error 4.29
|
78.2 units on a scale
Standard Error 4.27
|
6.9 units on a scale
Standard Error 8.56
|
SECONDARY outcome
Timeframe: 240 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
|
97.0 units on a scale
Standard Error 4.47
|
74.6 units on a scale
Standard Error 4.46
|
11.2 units on a scale
Standard Error 8.93
|
SECONDARY outcome
Timeframe: 300 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
|
90.1 units on a scale
Standard Error 4.62
|
67.6 units on a scale
Standard Error 4.60
|
13.7 units on a scale
Standard Error 9.22
|
SECONDARY outcome
Timeframe: 360 MinutesPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Sum of PID and PAR Scores (PRID) at each Assessment Time point - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
|
81.4 units on a scale
Standard Error 4.66
|
60.4 units on a scale
Standard Error 4.64
|
15.0 units on a scale
Standard Error 9.31
|
SECONDARY outcome
Timeframe: within 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Minutes until meaningful pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
Outcome measures
| Measure |
ACE-1000
n=238 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Time to Meaningful Pain Relief
|
53.7 Minutes
Interval 9.3 to 360.0
|
56.1 Minutes
Interval 15.9 to 360.0
|
NA Minutes
Data for the placebo group are not available. Median was not estimable since fewer than 50% of the subjects treated with Placebo obtained meaningful pain relief.
|
SECONDARY outcome
Timeframe: within 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Minutes until confirmed perceptible pain relief was achieved. A stopwatch was provided to the subject after ingestion of the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief. It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Time to Confirmed Perceptible Pain Relief
|
22.2 Minutes
Interval 3.8 to 360.0
|
22.2 Minutes
Interval 3.8 to 360.0
|
NA Minutes
Data for the placebo group are not available. Median was not estimable because fewer than 50% of the subjects treated with Placebo obtained perceptible pain relief.
|
SECONDARY outcome
Timeframe: within 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Minutes until rescue medication was given.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Duration of Analgesia - Time to Rescue
|
NA Minutes
Data for the acetaminophen 1000 mg group are not available. Median was not estimable since fewer than 50% of the subjects treated with acetaminophen 1000 mg rescued.
|
NA Minutes
Data for the acetaminophen 650 mg group are not available. Median was not estimable since fewer than 50% of the subjects treated with acetaminophen 650 mg rescued.
|
99.5 Minutes
Interval 92.0 to 360.0
|
SECONDARY outcome
Timeframe: through 4 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Percentage of subjects using rescue medication.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Rescue Rates Through Four Hours
|
20.1 Percentage of Participants
|
32.4 Percentage of Participants
|
80.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: through 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Percentage of subjects using rescue medication.
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Rescue Rates Through Six Hours
|
29.3 Percentage of Participants
|
45.6 Percentage of Participants
|
80.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
Percentage of Subjects with \>50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so \>50% is \>300 out of 600
Outcome measures
| Measure |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
|
56.9 Percentage of Participants
|
44.4 Percentage of Participants
|
6.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 HoursPopulation: Analysis is based on the Intent-to-Treat (ITT) set, which included all subjects who were randomized, took study medication, did not vomit within 60 minutes after dosing, and had a baseline pain score and at least one post-randomization assessment.
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 |
ACE-1000
n=239 Participants
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 Participants
650 mg Acetaminophen Caplet
|
ACE-0
n=60 Participants
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Patient Global Evaluation
|
2.28 Units on a scale
Standard Error 0.073
|
1.95 Units on a scale
Standard Error 0.073
|
0.60 Units on a scale
Standard Error 0.146
|
Adverse Events
ACE-1000
ACE-650
ACE-0
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ACE-1000
n=239 participants at risk
1000 mg Acetaminophen Caplet
|
ACE-650
n=241 participants at risk
650 mg Acetaminophen Caplet
|
ACE-0
n=60 participants at risk
0 mg Acetaminophen Caplet
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
12.1%
29/239 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
10.8%
26/241 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
15.0%
9/60 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
|
Gastrointestinal disorders
Vomiting
|
4.6%
11/239 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
4.6%
11/241 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
6.7%
4/60 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
|
Nervous system disorders
Dizziness
|
4.2%
10/239 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
3.3%
8/241 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
6.7%
4/60 • 6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
|
Additional Information
Joyce Hauze, RPS Sr Specialist, Clinical Research Operations
Johnson & Johnson Consumer and Personal Products Worldwide
Results disclosure agreements
- Principal investigator is a sponsor employee The results may not be published or referred to at research seminars, lectures or professional meetings, in whole or in part, without the prior written consent of McNeil Consumer Healthcare, to be given or withheld at McNeil Consumer Healthcare's sole and absolute discretion
- Publication restrictions are in place
Restriction type: OTHER