Efficacy and Safety Study of a Test Naproxen Sodium 220mg Tablet in Postoperative Dental Pain

Study Overview
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Brief Summary
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To evaluate analgesic onset, efficacy, and safety of a single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets compared with two commercial naproxen sodium products (two naproxen sodium 220 mg tablets and two naproxen sodium 220 mg liquid gels capsules) and placebo in the dental pain model following third-molar extractions.

Detailed Description
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This is a single-dose, randomized, double-blind, placebo- and active- controlled, parallel-group study to evaluate the analgesic onset, efficacy, and safety profile of 440 mg of naproxen sodium administered as two Test NPX 220 mg tablets compared with two commercial products and placebo over a twelve-hour period after third-molar extractions. Subjects will undergo dental extraction of three or four third molars.

Official Title
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A Randomized, Double-Blind, Placebo- and Active- Controlled, Efficacy and Safety Study of a Test Naproxen Sodium 220 mg Tablet in Postoperative Dental Pain

Conditions
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Post-operative Dental Pain

Intervention / Treatment
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* Drug: Test naproxen sodium tablet
* Drug: Commercial naproxen sodium tablet
* Drug: Commercial naproxen sodium liquid gels capsule
* Drug: Placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17 - 50 years old Weigh 100 pounds or greater and have a body mass index (BMI) of 17.5 to 30.4 (inclusive) at screening Dental extraction of three or four third molars Meets post-surgical pain 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 be 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, hydrocodone or other opioids Not able to swallow 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, substance abuse as judged by investigator site staff within last 5 years Use of immunosuppressive drugs within 2 weeks of screening History of endoscopically documented peptic ulcer disease or bleeding disorder in last 2 years

Ages Eligible for Study
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Minimum Age: 17 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: Post-operative dental pain following third molar extraction.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test naproxen sodium tablet<br>Single dose of 440 mg of naproxen sodium administered as two Test Naproxen Sodium 220 mg tablets (Test NPX) | Drug: Test naproxen sodium tablet<br>* Single dose of 2 test naproxen sodium 220 mg tablets<br>* Other names: Test NPX tablet;|
| Active Comparator: Commercial naproxen sodium tablet<br>Single dose of 440 mg of naproxen sodium administered as two commercial naproxen sodium 220 mg tablets | Drug: Commercial naproxen sodium tablet<br>* Single dose of 2 naproxen sodium 220 mg tablets<br>* Other names: Commercial NPX tablet;|
| Active Comparator: Commercial naproxen sodium liquid gels capsule<br>Single dose of 440 mg of naproxen sodium administered as two 220 mg commercial liquid gels capsules | Drug: Commercial naproxen sodium liquid gels capsule<br>* Single dose of 2 naproxen sodium 220 mg liquid gel capsules<br>* Other names: Commercial NPX liquid gels capsule;|
| Placebo Comparator: Placebo tablet<br>Single dose of two Placebo tablets | Drug: Placebo tablet<br>* 2 placebo tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Confirmed Perceptible Pain Relief | Minutes until confirmed first perceptible pain relief was achieved. Stopwatch is started after the participant takes the study medication. The participant is instructed to stop the stopwatch when they first begin to feel any pain relief. The first perceptible pain relief is confirmed if the participant also stopped the second stopwatch indicating meaningful pain relief. | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Confirmed Perceptible Pain Relief From 45 Minutes to Successively Earlier Minutes in One-minute Increments | Percentage of participants with confirmed perceptible pain relief from 45 minutes to successively earlier minutes in one-minute increments were reported. | Up to 45 minutes after dosing |