Pain
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
Detailed description
This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative dental pain.
Interventions
DRUGAcetaminophen
Acetaminophen Caplet - single dose
DRUGPlacebo Control
0 mg Caplet - single dose
Sponsors
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Must be at least 16 and less than 51 years of age * Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30 * Must have up to four of their back teeth (third-molars) pulled
Exclusion criteria
* Cannot be allergic to acetaminophen (Tylenol) * Cannot be pregnant (or planning to be pregnant) or nursing a baby * Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) | 6 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sum of Pain Intensity Difference Over Six Hours (SPID6) | 6 Hours | 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. |
| Sum of Pain Relief Scores Over Six Hours (TOTPAR6) | 6 Hours | 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. |
| Pain Intensity Difference (PID) at 15 Minutes | 15 Minutes | 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. |
| Pain Intensity Difference (PID) at 30 Minutes | 30 Minutes | 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. |
| Pain Intensity Difference (PID) at 45 Minutes | 45 Minutes | 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. |
| Pain Intensity Difference (PID) at 60 Minutes | 60 Minutes | 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. |
| Pain Intensity Difference (PID) at 75 Minutes | 75 Minutes | 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. |
| Pain Intensity Difference (PID) at 90 Minutes | 90 Minutes | 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. |
| Pain Intensity Difference (PID) at 120 Minutes | 120 Minutes | 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. |
| Pain Intensity Difference (PID) at 180 Minutes | 180 Minutes | 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. |
| Pain Intensity Difference (PID) at 240 Minutes | 240 Minutes | 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. |
| Pain Intensity Difference (PID) at 300 Minutes | 300 Minutes | 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. |
| Pain Intensity Difference (PID) at 360 Minutes | 360 Minutes | 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. |
| Pain Relief (PAR) Scores at 15 Minutes | 15 Minutes | 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 |
| Pain Relief (PAR) Scores at 30 Minutes | 30 Minutes | 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 |
| Pain Relief (PAR) Scores at 45 Minutes | 45 Minutes | 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 |
| Pain Relief (PAR) Scores at 60 Minutes | 60 Minutes | 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 |
| Pain Relief (PAR) Scores at 75 Minutes | 75 Minutes | 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 |
| Pain Relief (PAR) Scores at 120 Minutes | 120 Minutes | 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 |
| Pain Relief (PAR) Scores at 180 Minutes | 180 Minutes | 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 |
| Pain Relief (PAR) Scores at 240 Minutes | 240 Minutes | 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 |
| Pain Relief (PAR) Scores at 300 Minutes | 300 Minutes | 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 |
| Pain Relief (PAR) Scores at 360 Minutes | 360 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes | 15 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes | 30 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes | 45 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes | 60 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes | 75 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes | 90 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes | 120 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes | 180 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes | 240 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes | 300 Minutes | 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 |
| Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes | 360 Minutes | 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 |
| Time to Meaningful Pain Relief | within 6 Hours | 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. |
| Time to Confirmed Perceptible Pain Relief | within 6 Hours | 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. |
| Pain Relief (PAR) Scores at 90 Minutes | 90 Minutes | 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 |
| Rescue Rates Through Four Hours | through 4 Hours | Percentage of subjects using rescue medication. |
| Rescue Rates Through Six Hours | through 6 Hours | Percentage of subjects using rescue medication. |
| Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score | 6 Hours | 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 |
| Patient Global Evaluation | 6 Hours | 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 |
| Duration of Analgesia - Time to Rescue | within 6 Hours | Minutes until rescue medication was given. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACE-1000 1000 mg Acetaminophen Caplet | 239 |
| ACE-650 650 mg Acetaminophen Caplet | 241 |
| ACE-0 0 mg Acetaminophen Caplet | 60 |
| Total | 540 |
Baseline characteristics
| Characteristic | ACE-1000 | ACE-650 | ACE-0 | Total |
|---|---|---|---|---|
| Age Continuous | 18.5 years STANDARD_DEVIATION 2.24 | 18.3 years STANDARD_DEVIATION 1.96 | 18.1 years STANDARD_DEVIATION 2.02 | 18.4 years STANDARD_DEVIATION 2.09 |
| Region of Enrollment United States | 239 participants | 241 participants | 60 participants | 540 participants |
| Sex: Female, Male Female | 131 Participants | 120 Participants | 31 Participants | 282 Participants |
| Sex: Female, Male Male | 108 Participants | 121 Participants | 29 Participants | 258 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 239 | 42 / 241 | 13 / 60 |
| serious Total, serious adverse events | 0 / 239 | 0 / 241 | 0 / 60 |
Outcome results
Primary
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
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.
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | 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 |
| ACE-650 | Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) | 427.3 units on a scale | Standard Error 22.21 |
| ACE-0 | Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) | 60.0 units on a scale | Standard Error 44.51 |
Comparison: First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.p-value: <0.001ANOVA
Comparison: First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.p-value: 0.001ANOVA
Comparison: First test H1: acetaminophen 1000 mg vs placebo at the alpha = 0.025 one-tail level; If H1 was rejected then, Test H2: acetaminophen 1000 mg vs acetaminophen 650 mg, and Test H3: acetaminophen 650 mg vs placebo; H2 and H3 were each tested at the alpha = 0.025 one-tail level.p-value: <0.001ANOVA
Secondary
Duration of Analgesia - Time to Rescue
Minutes until rescue medication was given.
Time frame: within 6 Hours
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACE-1000 | Duration of Analgesia - Time to Rescue | NA Minutes |
| ACE-650 | Duration of Analgesia - Time to Rescue | NA Minutes |
| ACE-0 | Duration of Analgesia - Time to Rescue | 99.5 Minutes |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.p-value: <0.001Log Rank
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.p-value: <0.001Log Rank
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. Subjects not rescuing during the 6-hour study period had their time to rescue set to 6 hours and were censored.p-value: <0.001Log Rank
Secondary
Pain Intensity Difference (PID) at 120 Minutes
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.
Time frame: 120 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 120 Minutes | 44.8 units on a scale | Standard Error 2 |
| ACE-650 | Pain Intensity Difference (PID) at 120 Minutes | 35.7 units on a scale | Standard Error 1.99 |
| ACE-0 | Pain Intensity Difference (PID) at 120 Minutes | -2.7 units on a scale | Standard Error 3.99 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 15 Minutes
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.
Time frame: 15 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 15 Minutes | 5.6 units on a scale | Standard Error 0.92 |
| ACE-650 | Pain Intensity Difference (PID) at 15 Minutes | 6.9 units on a scale | Standard Error 0.91 |
| ACE-0 | Pain Intensity Difference (PID) at 15 Minutes | 1.3 units on a scale | Standard Error 1.83 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.037ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.294ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.006ANOVA
Secondary
Pain Intensity Difference (PID) at 180 Minutes
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.
Time frame: 180 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 180 Minutes | 40.8 units on a scale | Standard Error 2.03 |
| ACE-650 | Pain Intensity Difference (PID) at 180 Minutes | 31.9 units on a scale | Standard Error 2.02 |
| ACE-0 | Pain Intensity Difference (PID) at 180 Minutes | -2.6 units on a scale | Standard Error 4.05 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 240 Minutes
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.
Time frame: 240 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 240 Minutes | 40.8 units on a scale | Standard Error 2.11 |
| ACE-650 | Pain Intensity Difference (PID) at 240 Minutes | 30.3 units on a scale | Standard Error 2.1 |
| ACE-0 | Pain Intensity Difference (PID) at 240 Minutes | -1.1 units on a scale | Standard Error 4.2 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 300 Minutes
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.
Time frame: 300 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 300 Minutes | 37.9 units on a scale | Standard Error 2.17 |
| ACE-650 | Pain Intensity Difference (PID) at 300 Minutes | 27.1 units on a scale | Standard Error 2.16 |
| ACE-0 | Pain Intensity Difference (PID) at 300 Minutes | -0.1 units on a scale | Standard Error 4.32 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 30 Minutes
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.
Time frame: 30 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 30 Minutes | 21.3 units on a scale | Standard Error 1.48 |
| ACE-650 | Pain Intensity Difference (PID) at 30 Minutes | 21.5 units on a scale | Standard Error 1.47 |
| ACE-0 | Pain Intensity Difference (PID) at 30 Minutes | 0.5 units on a scale | Standard Error 2.95 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.946ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 360 Minutes
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.
Time frame: 360 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 360 Minutes | 33.4 units on a scale | Standard Error 2.19 |
| ACE-650 | Pain Intensity Difference (PID) at 360 Minutes | 23.8 units on a scale | Standard Error 2.18 |
| ACE-0 | Pain Intensity Difference (PID) at 360 Minutes | 1.0 units on a scale | Standard Error 4.37 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 45 Minutes
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.
Time frame: 45 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 45 Minutes | 33.9 units on a scale | Standard Error 1.71 |
| ACE-650 | Pain Intensity Difference (PID) at 45 Minutes | 32.8 units on a scale | Standard Error 1.71 |
| ACE-0 | Pain Intensity Difference (PID) at 45 Minutes | 0.2 units on a scale | Standard Error 3.42 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.661ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 60 Minutes
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.
Time frame: 60 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 60 Minutes | 40.4 units on a scale | Standard Error 1.82 |
| ACE-650 | Pain Intensity Difference (PID) at 60 Minutes | 36.6 units on a scale | Standard Error 1.81 |
| ACE-0 | Pain Intensity Difference (PID) at 60 Minutes | -0.1 units on a scale | Standard Error 3.62 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.13ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 75 Minutes
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.
Time frame: 75 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 75 Minutes | 43.1 units on a scale | Standard Error 1.88 |
| ACE-650 | Pain Intensity Difference (PID) at 75 Minutes | 37.6 units on a scale | Standard Error 1.87 |
| ACE-0 | Pain Intensity Difference (PID) at 75 Minutes | -0.9 units on a scale | Standard Error 3.74 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.041ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Intensity Difference (PID) at 90 Minutes
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.
Time frame: 90 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Intensity Difference (PID) at 90 Minutes | 44.4 units on a scale | Standard Error 1.93 |
| ACE-650 | Pain Intensity Difference (PID) at 90 Minutes | 38.0 units on a scale | Standard Error 1.92 |
| ACE-0 | Pain Intensity Difference (PID) at 90 Minutes | -0.6 units on a scale | Standard Error 3.85 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.02ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 120 Minutes
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
Time frame: 120 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 120 Minutes | 60.3 units on a scale | Standard Error 2.25 |
| ACE-650 | Pain Relief (PAR) Scores at 120 Minutes | 50.8 units on a scale | Standard Error 2.24 |
| ACE-0 | Pain Relief (PAR) Scores at 120 Minutes | 8.0 units on a scale | Standard Error 4.49 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.003ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 15 Minutes
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
Time frame: 15 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 15 Minutes | 8.3 units on a scale | Standard Error 1.09 |
| ACE-650 | Pain Relief (PAR) Scores at 15 Minutes | 9.4 units on a scale | Standard Error 1.09 |
| ACE-0 | Pain Relief (PAR) Scores at 15 Minutes | 3.0 units on a scale | Standard Error 2.18 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.028ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.462ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.008ANOVA
Secondary
Pain Relief (PAR) Scores at 180 Minutes
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
Time frame: 180 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 180 Minutes | 56.3 units on a scale | Standard Error 2.31 |
| ACE-650 | Pain Relief (PAR) Scores at 180 Minutes | 46.3 units on a scale | Standard Error 2.3 |
| ACE-0 | Pain Relief (PAR) Scores at 180 Minutes | 9.5 units on a scale | Standard Error 4.61 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 240 Minutes
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
Time frame: 240 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 240 Minutes | 56.2 units on a scale | Standard Error 2.41 |
| ACE-650 | Pain Relief (PAR) Scores at 240 Minutes | 44.3 units on a scale | Standard Error 2.4 |
| ACE-0 | Pain Relief (PAR) Scores at 240 Minutes | 12.3 units on a scale | Standard Error 4.81 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 300 Minutes
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
Time frame: 300 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 300 Minutes | 52.2 units on a scale | Standard Error 2.49 |
| ACE-650 | Pain Relief (PAR) Scores at 300 Minutes | 40.5 units on a scale | Standard Error 2.48 |
| ACE-0 | Pain Relief (PAR) Scores at 300 Minutes | 13.8 units on a scale | Standard Error 4.97 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 30 Minutes
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
Time frame: 30 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 30 Minutes | 29.6 units on a scale | Standard Error 1.84 |
| ACE-650 | Pain Relief (PAR) Scores at 30 Minutes | 29.9 units on a scale | Standard Error 1.83 |
| ACE-0 | Pain Relief (PAR) Scores at 30 Minutes | 4.8 units on a scale | Standard Error 3.66 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.907ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 360 Minutes
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
Time frame: 360 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 360 Minutes | 48.0 units on a scale | Standard Error 2.51 |
| ACE-650 | Pain Relief (PAR) Scores at 360 Minutes | 36.6 units on a scale | Standard Error 2.5 |
| ACE-0 | Pain Relief (PAR) Scores at 360 Minutes | 14.0 units on a scale | Standard Error 5.02 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 45 Minutes
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
Time frame: 45 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 45 Minutes | 46.1 units on a scale | Standard Error 2.1 |
| ACE-650 | Pain Relief (PAR) Scores at 45 Minutes | 44.8 units on a scale | Standard Error 2.09 |
| ACE-0 | Pain Relief (PAR) Scores at 45 Minutes | 7.9 units on a scale | Standard Error 4.18 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.655ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 60 Minutes
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
Time frame: 60 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 60 Minutes | 54.4 units on a scale | Standard Error 2.16 |
| ACE-650 | Pain Relief (PAR) Scores at 60 Minutes | 50.1 units on a scale | Standard Error 2.15 |
| ACE-0 | Pain Relief (PAR) Scores at 60 Minutes | 8.3 units on a scale | Standard Error 4.3 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.155ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 75 Minutes
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
Time frame: 75 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 75 Minutes | 58.0 units on a scale | Standard Error 2.18 |
| ACE-650 | Pain Relief (PAR) Scores at 75 Minutes | 52.0 units on a scale | Standard Error 2.17 |
| ACE-0 | Pain Relief (PAR) Scores at 75 Minutes | 8.4 units on a scale | Standard Error 4.35 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.05ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Pain Relief (PAR) Scores at 90 Minutes
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
Time frame: 90 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Pain Relief (PAR) Scores at 90 Minutes | 59.9 units on a scale | Standard Error 2.22 |
| ACE-650 | Pain Relief (PAR) Scores at 90 Minutes | 53.1 units on a scale | Standard Error 2.21 |
| ACE-0 | Pain Relief (PAR) Scores at 90 Minutes | 10.1 units on a scale | Standard Error 4.43 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.032ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Patient Global Evaluation
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
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Patient Global Evaluation | 2.28 Units on a scale | Standard Error 0.073 |
| ACE-650 | Patient Global Evaluation | 1.95 Units on a scale | Standard Error 0.073 |
| ACE-0 | Patient Global Evaluation | 0.60 Units on a scale | Standard Error 0.146 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
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
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACE-1000 | Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score | 56.9 Percentage of Participants |
| ACE-650 | Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score | 44.4 Percentage of Participants |
| ACE-0 | Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score | 6.7 Percentage of Participants |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.006Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Rescue Rates Through Four Hours
Percentage of subjects using rescue medication.
Time frame: through 4 Hours
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACE-1000 | Rescue Rates Through Four Hours | 20.1 Percentage of Participants |
| ACE-650 | Rescue Rates Through Four Hours | 32.4 Percentage of Participants |
| ACE-0 | Rescue Rates Through Four Hours | 80.0 Percentage of Participants |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Rescue Rates Through Six Hours
Percentage of subjects using rescue medication.
Time frame: through 6 Hours
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ACE-1000 | Rescue Rates Through Six Hours | 29.3 Percentage of Participants |
| ACE-650 | Rescue Rates Through Six Hours | 45.6 Percentage of Participants |
| ACE-0 | Rescue Rates Through Six Hours | 80.0 Percentage of Participants |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
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
Time frame: 120 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes | 105.1 units on a scale | Standard Error 4.2 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes | 86.5 units on a scale | Standard Error 4.18 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes | 5.3 units on a scale | Standard Error 8.38 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
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
Time frame: 15 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes | 13.9 units on a scale | Standard Error 1.95 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes | 16.4 units on a scale | Standard Error 1.94 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes | 4.2 units on a scale | Standard Error 3.89 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.027ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.365ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.005ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
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
Time frame: 180 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes | 97.1 units on a scale | Standard Error 4.29 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes | 78.2 units on a scale | Standard Error 4.27 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes | 6.9 units on a scale | Standard Error 8.56 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
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
Time frame: 240 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes | 97.0 units on a scale | Standard Error 4.47 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes | 74.6 units on a scale | Standard Error 4.46 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes | 11.2 units on a scale | Standard Error 8.93 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
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
Time frame: 300 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes | 90.1 units on a scale | Standard Error 4.62 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes | 67.6 units on a scale | Standard Error 4.6 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes | 13.7 units on a scale | Standard Error 9.22 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
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
Time frame: 30 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes | 50.9 units on a scale | Standard Error 3.26 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes | 51.3 units on a scale | Standard Error 3.24 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes | 5.2 units on a scale | Standard Error 6.5 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.923ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
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
Time frame: 360 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes | 81.4 units on a scale | Standard Error 4.66 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes | 60.4 units on a scale | Standard Error 4.64 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes | 15.0 units on a scale | Standard Error 9.31 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
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
Time frame: 45 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes | 80.0 units on a scale | Standard Error 3.76 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes | 77.6 units on a scale | Standard Error 3.74 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes | 8.1 units on a scale | Standard Error 7.49 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.653ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
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
Time frame: 60 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes | 94.9 units on a scale | Standard Error 3.92 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes | 86.7 units on a scale | Standard Error 3.9 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes | 8.2 units on a scale | Standard Error 7.81 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.138ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
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
Time frame: 75 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes | 101.1 units on a scale | Standard Error 4 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes | 89.6 units on a scale | Standard Error 3.99 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes | 7.4 units on a scale | Standard Error 7.99 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.043ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
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
Time frame: 90 Minutes
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes | 104.2 units on a scale | Standard Error 4.1 |
| ACE-650 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes | 91.2 units on a scale | Standard Error 4.08 |
| ACE-0 | Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes | 9.4 units on a scale | Standard Error 8.18 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.024ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Intensity Difference Over Six Hours (SPID6)
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.
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Intensity Difference Over Six Hours (SPID6) | 222.5 units on a scale | Standard Error 10.49 |
| ACE-650 | Sum of Pain Intensity Difference Over Six Hours (SPID6) | 174.3 units on a scale | Standard Error 10.44 |
| ACE-0 | Sum of Pain Intensity Difference Over Six Hours (SPID6) | -4.2 units on a scale | Standard Error 20.93 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
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.
Time frame: 6 Hours
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ACE-1000 | Sum of Pain Relief Scores Over Six Hours (TOTPAR6) | 306.9 units on a scale | Standard Error 12.02 |
| ACE-650 | Sum of Pain Relief Scores Over Six Hours (TOTPAR6) | 253.0 units on a scale | Standard Error 11.96 |
| ACE-0 | Sum of Pain Relief Scores Over Six Hours (TOTPAR6) | 64.3 units on a scale | Standard Error 23.98 |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.002ANOVA
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001ANOVA
Secondary
Time to Confirmed Perceptible Pain Relief
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.
Time frame: within 6 Hours
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACE-1000 | Time to Confirmed Perceptible Pain Relief | 22.2 Minutes |
| ACE-650 | Time to Confirmed Perceptible Pain Relief | 22.2 Minutes |
| ACE-0 | Time to Confirmed Perceptible Pain Relief | NA Minutes |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Wilcoxon test, from SAS PROC LIFETEST
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.934Wilcoxon test, from SAS PROC LIFETEST
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Wilcoxon test, from SAS PROC LIFETEST
Secondary
Time to Meaningful Pain Relief
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.
Time frame: within 6 Hours
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ACE-1000 | Time to Meaningful Pain Relief | 53.7 Minutes |
| ACE-650 | Time to Meaningful Pain Relief | 56.1 Minutes |
| ACE-0 | Time to Meaningful Pain Relief | NA Minutes |
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Wilcoxon test, from SAS PROC LIFETEST
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: 0.26Wilcoxon test, from SAS PROC LIFETEST
Comparison: The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups.p-value: <0.001Wilcoxon test, from SAS PROC LIFETEST