Study of Acetaminophen (ACM) in Post-operative Dental Pain

Study Overview
=================
Brief Summary
-----------------
This is a Dental Pain Study which will evaluate the analgesic onset, efficacy and safety of 1000 mg acetaminophen as two Test acetaminophen 500 mg tablets, compared with commercial products of acetaminophen 1000 mg administered as two 500 mg caplets, and ibuprofen (IBU) 400 mg following third molar (wisdom tooth) extraction.

Detailed Description
-----------------
This is a single-dose, randomized, double-blind, triple-dummy, placebo- and active controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of Test acetaminophen 1000 mg compared with two commercial products over a six-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Active- Controlled, Single-Dose, Efficacy, Safety, and Pharmacokinetics Study of a Test Acetaminophen 500 mg Tablet in Postoperative Dental Pain

Conditions
-----------------
Post Operative Dental Pain

Intervention / Treatment
-----------------
* Drug: acetaminophen Tablet
* Drug: acetaminophen Caplet
* Drug: ibuprofen Liquid-filled capsule
* Drug: Placebo Tablet
* Drug: Placebo Caplet
* Drug: Placebo Liquid-filled capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 17 years to 50 years old Weight 100 lbs or greater with a body mass index (BMI) 18-30 inclusive Dental extraction of three or four molars Experience moderate to severe pain after extraction of third molars Females of childbearing age must be willing to use acceptable method of birth control Exclusion Criteria: Currently pregnant or planning to be pregnant or nursing a baby Known allergy to acetaminophen (ACM) or non-steroidal anti-inflammatory drugs (NSAIDS) Inability to swallow whole large tablets or capsules Have other conditions that the investigator feels may impact subject's safety and/or the integrity of the study

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test acetaminophen<br>acetaminophen tablet and placebo caplet and placebo liquid-filled capsule | Drug: acetaminophen Tablet<br>* 2 test acetaminophen 500 mg tablets<br>* Other names: Test ACM;Drug: Placebo Caplet<br>* 2 placebo caplets<br>Drug: Placebo Liquid-filled capsule<br>* 2 placebo Liquid-filled capsules<br>|
| Active Comparator: Commercial acetaminophen<br>acetaminophen caplet and placebo tablet and placebo liquid-filled capsule | Drug: acetaminophen Caplet<br>* 2 commercial acetaminophen 500 mg caplets<br>* Other names: Commercial ACM;Drug: Placebo Tablet<br>* 2 placebo tablets<br>Drug: Placebo Liquid-filled capsule<br>* 2 placebo Liquid-filled capsules<br>|
| Active Comparator: Commercial ibuprofen<br>ibuprofen liquid-filled capsule and placebo tablet and placebo caplet | Drug: ibuprofen Liquid-filled capsule<br>* 2 commercial ibuprofen 200 mg Liquid-filled capsules<br>* Other names: Commercial IBU;Drug: Placebo Tablet<br>* 2 placebo tablets<br>Drug: Placebo Caplet<br>* 2 placebo caplets<br>|
| Placebo Comparator: Placebo<br>Placebo tablet and placebo caplet and placebo liquid-filled capsule | Drug: Placebo Tablet<br>* 2 placebo tablets<br>Drug: Placebo Caplet<br>* 2 placebo caplets<br>Drug: Placebo Liquid-filled capsule<br>* 2 placebo Liquid-filled capsules<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first confirmed perceptible pain relief | Minutes until confirmed first perceptible pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subject is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the subject also stopped the second stopwatch indicating meaningful pain relief. | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with confirmed perceptible relief from 30 minutes to successively earlier minutes in one-minute increments (Test ACM versus placebo) |  | 30 minutes or less | 
| Risk ratios of confirmed perceptible relief by 10 minutes (Test acetominophen and commercial ibuprofen) | The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 10 minutes | 10 minutes or less | 
| Risk ratios of confirmed perceptible relief by 15 minutes (Test acetominophen and commercial ibuprofen) | The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 15 minutes | 15 minutes or less | 
| Risk ratios of confirmed perceptible relief by 20 minutes (Test acetominophen and commercial ibuprofen) | The risk ratios and confidence intervals for incidence of confirmed perceptible relief of Test ACM divided by commercial IBU will be presented for 20 minutes | 20 minutes or less | 
| Percentage of subjects with meaningful relief by 30 minutes |  | 30 minutes or less | 
| Time to meaningful pain relief | Minutes until meaningful pain relief are achieved. Stopwatch is started after the subject takes the study medication. The subjects are instructed to stop the stopwatch when the relief from the starting pain is meaningful to them. | 6 hours |