A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate how well a fixed combination of acetaminophen/naproxen sodium relieves postoperative dental pain compared with acetaminophen, naproxen sodium and placebo.

Official Title
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A Full-Factorial, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose Efficacy and Safety Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen, and Naproxen Sodium in Postoperative Dental Pain

Conditions
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Pain

Intervention / Treatment
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* Drug: Acetaminophen/Naproxen Sodium Fixed Combination
* Drug: Naproxen Sodium
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening Surgical removal of three or four third molars, of which, two must be mandibular impactions Meets requirements for post-surgical pain level Females of childbearing potential and males agree to contraceptive requirements of study Have a negative urine drug screen at screening, and on day of surgical procedure Exclusion Criteria: Pregnant female, breastfeeding, trying to become pregnant or male with pregnant partner or partner currently trying to become pregnant Have a known allergy or hypersensitivity to naproxen (or other NSAIDs including aspirin) or to acetaminophen, oxycodone or other opioids Not able to swallow whole large tablets or capsules History of any condition(s) in investigator's opinion, may jeopardize subject safety, well-being and integrity of study Use analgesics 5 or more times per week History of chronic tranquilizer use, heavy drinking, or substance abuse, as judged by the investigator site staff, in the last 5 years Use any immunosuppressive drugs within 2 weeks of surgical procedure History of endoscopically documented peptic ulcer disease or bleeding disorder in the last 2 years

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
Interventional Model Description: Postoperative dental pain following third molar extraction.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen/Naproxen Sodium Fixed Combination<br>Participants will receive a single oral dose of two Acetaminophen/Naproxen Sodium Fixed Combination tablets. | Drug: Acetaminophen/Naproxen Sodium Fixed Combination<br>* Fixed combination of Acetaminophen/Naproxen Sodium will be administered orally.<br>|
| Active Comparator: Naproxen Sodium<br>Participants will receive a single oral dose of one Naproxen Sodium tablet with one Placebo capsule. | Drug: Naproxen Sodium<br>* Naproxen Sodium will be administered orally.<br>Drug: Placebo<br>* Placebo will be administered orally.<br>|
| Active Comparator: Acetaminophen<br>Participants will receive a single oral dose of two Acetaminophen tablets. | Drug: Acetaminophen<br>* Acetaminophen will be administered orally.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single oral dose of two Placebo capsules. | Drug: Placebo<br>* Placebo will be administered orally.<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 from 0 to 12 Hours After Dosing (SPID 0-12) | Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the Pain Intensity-Numerical Rating Scale (PI-NRS) ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. | 0 to 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-weighted Sum of Pain Intensity Difference From 6 to 12 Hours (SPID 6-12) | Time-weighted sum of pain intensity difference (SPID) scores will be calculated using values collected on the PI-NRS ranging from 0-10 (0 = no pain, 10 = very severe pain) collected at each scheduled timepoint within the specified timeframe. | 6 to 12 hours | 
| Time to First Request of Rescue Analgesic | Time to first request for rescue medication will be measured as the elapsed time from when investigational product (IP) was given until the time rescue medication was first requested. | 0 to 24 hours | 
| Percentage of Participants who Request Rescue Analgesic During the First 12 hours | Percentage of participants who request rescue analgesic during the first 12 hours will be reported. | 0 to 12 hours |