To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACE-1000<br>1000 mg Acetaminophen Caplet | Drug: Acetaminophen<br>* Acetaminophen Caplet - single dose<br>* Other names: Tylenol;|
| Active Comparator: ACE-650<br>650 mg Acetaminophen Caplet | Drug: Acetaminophen<br>* Acetaminophen Caplet - single dose<br>* Other names: Tylenol;|
| Placebo Comparator: ACE-0<br>0 mg Acetaminophen Caplet | Drug: Placebo Control<br>* 0 mg Caplet - single dose<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |