Study of Naproxen Capsules to Treat Dental Pain

Study Overview
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Brief Summary
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The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for the treatment of dental pain.

Official Title
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A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

Conditions
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Dental Pain

Intervention / Treatment
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* Drug: Naproxen Test
* Drug: Naproxen Test
* Drug: Naprosyn
* Drug: Naprosyn
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is male or female between 18 and 50 years of age For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control Patient requires extraction of 2 or more third molars Patient must be willing to stay at the study site overnight Exclusion Criteria: Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs Patient has a current disease or history of a disease that will impact the study or the patient's well-being Patient has used or intends to use any of the medications that are prohibited by the protocol Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test Patient has taken another investigational drug within 30 days prior to screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Naproxen Test (lower dose)<br>200-mg | Drug: Naproxen Test<br>* 200-mg single dose<br>|
| Experimental: Naproxen Test (upper dose)<br>400-mg (2 x 200-mg) | Drug: Naproxen Test<br>* 400-mg (2 x 200-mg)<br>|
| Active Comparator: Naprosyn 250 mg<br> | Drug: Naprosyn<br>* single dose<br>|
| Active Comparator: Naprosyn 500 mg<br> | Drug: Naprosyn<br>* single dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0 | Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60. | Over 0 to 12 Hours |