Study of Long-Acting Acetaminophen in Postoperative Dental Pain

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of acetaminophen ER 1500 mg (two 750 mg tablets) over 10 to 12 hours in the dental pain model following third molar extraction(s) and to evaluate the pharmacokinetics of acetaminophen ER 1500 mg (two 750 mg tablets) in a sub-group of subjects.

Official Title
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A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of Extended-Release (ER) Acetaminophen in Postoperative Dental Pain

Conditions
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Dental Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 17 and less than 46 years of age Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30 Scheduled to undergo surgical extraction of one impacted third molar from the lower jaw. The third molar from the upper jaw from the same side may also be removed. Experiencing moderate to severe pain after extraction of third molars. Exclusion Criteria: Cannot be allergic to acetaminophen (Tylenol) or any non-steroidal anti-inflammatory drugs (e.g., Motrin, Advil, Aleve, Naproxen). Cannot be pregnant (or planning to be pregnant) or nursing a baby Unable to swallow whole large tablets or caplets. Cannot have any other medical conditions that the investigator feels may compromise your safety or the study results.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen ER<br> | Drug: Acetaminophen ER<br>* Single dose (2 tablets) Acetaminophen ER 750 mg<br>|
| Placebo Comparator: Placebo<br>Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo | Drug: Placebo<br>* Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Weighted Sum of Pain Intensity Difference (PID) Over 10 Hours (SPID 0-10) | Time weighted sum of pain intensity difference scores from baseline over 10 hours. Pain intensity was evaluated using a 0-10 numerical rating scale (NRS) where 0 = no pain and 10 = very severe pain. SPID 0-10 = 0.25 x (PID at 15 min + PID at 30 min + PID at 45 min + PID at 60 min + PID at 75 min + PID at 90 min) + 0.5 x (PID at 120 min) + PID at 3 h + PID at 4 h + PID at 5 h + PID at 6 h + PID at 7 h + PID at 8 h + PID at 9 h + PID at 10 h. | 10 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Confirmed First Perceptible Pain Relief | Minutes until confirmed first perceptible pain relief was achieved. Stopwatch was started after the subject took the study medication. The subject was instructed to stop the stopwatch when they first began to feel any pain relief. The first perceptible pain relief was confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief. | Within 12 Hours | 
| Time to Meaningful Pain Relief | Minutes until meaningful pain relief was achieved. Stopwatch was started after the subject took the study medication. The subjects were instructed to stop the stopwatch when the relief from the starting pain was meaningful to them. | Within 12 Hours | 
| Duration of Pain Relief | Minutes until rescue medication was given. | Within 12 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. | 12 Hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetaminophen, Paracetamol Analgesics, Analgesics, Non-Narcotic Pain, Postoperative Pain, Antipyretics Dental Surgery, Third molar extraction