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The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACE-1000 | Experimental | 1000 mg Acetaminophen Caplet |
|
| ACE-650 | Active Comparator | 650 mg Acetaminophen Caplet |
|
| ACE-0 | Placebo Comparator | 0 mg Acetaminophen Caplet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Acetaminophen Caplet - single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Qi, M.D. | McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23200183 | Derived | Qi DS, May LG, Zimmerman B, Peng P, Atillasoy E, Brown JD, Cooper SA. A randomized, double-blind, placebo-controlled study of acetaminophen 1000 mg versus acetaminophen 650 mg for the treatment of postsurgical dental pain. Clin Ther. 2012 Dec;34(12):2247-2258.e3. doi: 10.1016/j.clinthera.2012.11.003. Epub 2012 Nov 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACE-1000 | 1000 mg Acetaminophen Caplet |
| FG001 | ACE-650 | 650 mg Acetaminophen Caplet |
| FG002 | ACE-0 | 0 mg Acetaminophen Caplet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACE-1000 | 1000 mg Acetaminophen Caplet |
| BG001 | ACE-650 | 650 mg Acetaminophen Caplet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 Hours |
|
6 Hours (+30 days for Serious Adverse Events)
The safety analysis set included all subjects who were randomized and took study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACE-1000 | 1000 mg Acetaminophen Caplet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joyce Hauze, RPS Sr Specialist, Clinical Research Operations | Johnson & Johnson Consumer and Personal Products Worldwide | 928-277-0715 | jhauze@its.jnj.com |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo Control | Drug | 0 mg Caplet - single dose |
|
|
| 6 Hours |
| 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. | 6 Hours |
| 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. | 15 Minutes |
| 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. | 30 Minutes |
| 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. | 45 Minutes |
| 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. | 60 Minutes |
| 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. | 75 Minutes |
| 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. | 90 Minutes |
| 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. | 120 Minutes |
| 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. | 180 Minutes |
| 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. | 240 Minutes |
| 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. | 300 Minutes |
| 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. | 360 Minutes |
| 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 | 15 Minutes |
| 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 | 30 Minutes |
| 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 | 45 Minutes |
| 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 | 60 Minutes |
| 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 | 75 Minutes |
| 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 | 90 Minutes |
| 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 | 120 Minutes |
| 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 | 180 Minutes |
| 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 | 240 Minutes |
| 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 | 300 Minutes |
| 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 | 360 Minutes |
| 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 | 15 Minutes |
| 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 | 30 Minutes |
| 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 | 45 Minutes |
| 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 | 60 Minutes |
| 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 | 75 Minutes |
| 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 | 90 Minutes |
| 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 | 120 Minutes |
| 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 | 180 Minutes |
| 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 | 240 Minutes |
| 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 | 300 Minutes |
| 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 | 360 Minutes |
| 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. | within 6 Hours |
| 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. | within 6 Hours |
| Duration of Analgesia - Time to Rescue | Minutes until rescue medication was given. | within 6 Hours |
| Rescue Rates Through Four Hours | Percentage of subjects using rescue medication. | through 4 Hours |
| Rescue Rates Through Six Hours | Percentage of subjects using rescue medication. | through 6 Hours |
| 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 | 6 Hours |
| 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 | 6 Hours |
| BG002 |
| ACE-0 |
0 mg Acetaminophen Caplet |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ACE-1000 |
1000 mg Acetaminophen Caplet |
| OG001 | ACE-650 | 650 mg Acetaminophen Caplet |
| OG002 | ACE-0 | 0 mg Acetaminophen Caplet |
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 Hours |
|
|
|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6 Hours |
|
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|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 15 Minutes |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 30 Minutes |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 45 Minutes |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 60 Minutes |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 75 Minutes |
|
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|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 Minutes |
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 120 Minutes |
|
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|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 180 Minutes |
|
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|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 240 Minutes |
|
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|
|
| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 300 Minutes |
|
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| 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. | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 360 Minutes |
|
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|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 15 Minutes |
|
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|
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| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 30 Minutes |
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|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 45 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 60 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 75 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 120 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 180 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 240 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 300 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 360 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 15 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 30 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 45 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 60 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 75 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 90 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 120 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 180 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 240 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 300 Minutes |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 360 Minutes |
|
|
|
|
| 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. | 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. | Posted | Median | Full Range | Minutes | within 6 Hours |
|
|
|
|
| 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. | 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. | Posted | Median | Full Range | Minutes | within 6 Hours |
|
|
|
|
| Secondary | Duration of Analgesia - Time to Rescue | Minutes until rescue medication was given. | 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. | Posted | Median | Full Range | Minutes | within 6 Hours |
|
|
|
|
| Secondary | Rescue Rates Through Four Hours | Percentage of subjects using rescue medication. | 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. | Posted | Number | Percentage of Participants | through 4 Hours |
|
|
|
|
| Secondary | Rescue Rates Through Six Hours | Percentage of subjects using rescue medication. | 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. | Posted | Number | Percentage of Participants | through 6 Hours |
|
|
|
|
| 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 | 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. | Posted | Number | Percentage of Participants | 6 Hours |
|
|
|
|
| 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 | 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. | Posted | Least Squares Mean | Standard Error | Units on a scale | 6 Hours |
|
|
|
|
| 0 |
| 239 |
| 45 |
| 239 |
| EG001 | ACE-650 | 650 mg Acetaminophen Caplet | 0 | 241 | 42 | 241 |
| EG002 | ACE-0 | 0 mg Acetaminophen Caplet | 0 | 60 | 13 | 60 |
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
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
| Aniline Compounds |
| D000588 | Amines |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 48.14 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 178.56 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 53.95 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 188.72 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.294 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -1.36 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | 0.006 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 5.66 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.946 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -0.14 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 20.99 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.661 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 1.06 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 32.62 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.13 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 3.88 |
| 95 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 36.67 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.041 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 5.42 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 38.55 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.02 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 6.34 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 38.63 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 9.08 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 38.38 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 8.83 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 34.59 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 10.57 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 31.42 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 10.82 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 27.22 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 9.58 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 22.87 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.462 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -1.13 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | 0.008 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 6.48 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.907 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -0.30 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 25.11 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.655 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 1.32 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 36.87 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.155 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 4.33 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 41.82 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.05 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 6.04 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 43.65 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.032 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 6.74 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 43.10 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.003 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 9.52 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 42.84 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 10.04 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 36.75 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 11.82 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 32.02 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 11.68 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 26.72 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 11.40 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 22.55 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.365 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -2.49 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | 0.005 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 12.14 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.923 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| -0.45 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 46.10 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.653 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 2.38 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 69.49 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.138 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 8.21 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 78.49 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.043 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 11.46 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 82.20 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.024 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 13.08 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 81.72 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 18.60 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 81.23 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 18.87 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 71.35 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 22.39 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 63.44 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 22.50 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 53.94 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 20.98 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 45.41 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| Wilcoxon test, from SAS PROC LIFETEST |
| 0.26 |
The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves. |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | Wilcoxon test, from SAS PROC LIFETEST | <0.001 | The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves. | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| Wilcoxon test, from SAS PROC LIFETEST |
| 0.934 |
The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves. |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | Wilcoxon test, from SAS PROC LIFETEST | <0.001 | The significance threshold level was 0.05 (two-sided). p-Values are based on the Wilcoxon test from PROC LIFETEST that compared survival curves. | No | Superiority or Other |
|
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. |
| Log Rank |
| <0.001 |
The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves. |
| No |
| Superiority or Other |
| 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. | Log Rank | <0.001 | The significance threshold level was 0.05 (two-sided). p-Values are based on the log-rank test from PROC LIFETEST that compared survival curves. | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| Cochran-Mantel-Haenszel |
Stratified by categorical baseline pain rating. |
| 0.002 |
The significance threshold level was 0.05 (two-sided). |
| Odds Ratio (OR) |
| 0.52 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | Cochran-Mantel-Haenszel | Stratified by categorical baseline pain rating. | <0.001 | The significance threshold level was 0.05 (two-sided). | Odds Ratio (OR) | 0.12 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| Cochran-Mantel-Haenszel |
Stratified by categorical baseline pain rating. |
| <0.001 |
The significance threshold level was 0.05 (two-sided). |
| Odds Ratio (OR) |
| 0.49 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | Cochran-Mantel-Haenszel | Stratified by categorical baseline pain rating. | <0.001 | The significance threshold level was 0.05 (two-sided). | Odds Ratio (OR) | 0.21 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| Cochran-Mantel-Haenszel |
Stratified by categorical baseline pain rating. |
| 0.006 |
The significance threshold level was 0.05 (two-sided). |
| Odds Ratio (OR) |
| 1.65 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | Cochran-Mantel-Haenszel | Stratified by categorical baseline pain rating. | <0.001 | The significance threshold level was 0.05 (two-sided). | Odds Ratio (OR) | 11.16 | No | Superiority or Other |
The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. |
| ANOVA |
Treatment and baseline pain categorical ratings were factors. |
| 0.001 |
The significance threshold level was 0.05 (two-sided). |
| Mean Difference (Final Values) |
| 0.33 |
| No |
| Superiority or Other |
| The null hypothesis was no difference between groups. The alternative hypothesis was a difference between groups. | ANOVA | Treatment and baseline pain categorical ratings were factors. | <0.001 | The significance threshold level was 0.05 (two-sided). | Mean Difference (Final Values) | 1.35 | No | Superiority or Other |