Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

Study Overview
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Brief Summary
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The purpose of the this study is to evaluate the sfaety and efficacy of Synera(R)for patients with lateral and medial epicondylitis and compare it to Naproxen sodius.

Detailed Description
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The objective of this single center is to evaluate the safety and efficacy of Synera ® in lateral and medial epicondylitis . This is an open-label, comaparative study study where the subjects will be randomized to one of the following groups: Synera patch ®: A single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow Naproxen Sodium: 500mg bid

Official Title
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Randomized, Parallel-Group, Open Label, Dose Finding Study to Evaluate the Efficacy of Synera Patch Compared to Naproxen Sodium for the Treatment of Lateral and Medial Epicondylitis of the Elbow

Conditions
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Epicondylitis of the Elbow

Intervention / Treatment
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* Drug: Naproxen
* Drug: Synera patch twice daily
* Drug: Synera patch for 12hrs/day
* Drug: Naproxen
* Drug: Synera
* Drug: Synera


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals with clinical evidence of lateral or medial epicondylitis of the elbow. Age 18 or higher Minimum of 4 on Question 5 of BPI Exclusion Criteria: Peripheral neuropathy of any origin in the index limb Cubital tunnel syndrome in patients with medial epicondylitis Cortisone injection in the last 4 weeks into the index limb Surgical intervention in the past for the epicondiitis Participants in any other clinical trial in the last 30 days Known allergy to lidocaine, tetracaine, NSAIDs or PABA Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator Patient who is deemed to be medically unstable by the principal investigator including but not limited to Liver disease or Cardiac arrhythmias Patients who are pregnant, lactating or breast feeding Vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naproxen<br> | Drug: Naproxen<br>* Naproxen 500mg BID for the first 2 weeks<br>Drug: Naproxen<br>* 500mg bid<br>|
| Experimental: Synera single patch applied for 12 hrs/day<br> | Drug: Synera patch for 12hrs/day<br>* 1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks<br>Drug: Synera<br>* Topical appication of single patch to elbow for 12hrs/day<br>|
| Experimental: Synera sinlgle patch applied for 4hrs twice daily<br> | Drug: Synera patch twice daily<br>* 1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks<br>Drug: Synera<br>* Single patch applied to elbow for 4hrs/twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily | Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit | Day 1 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain quality assessment scale | It is a vlaidated measure to assess the qulaity of scale | Every visit from the entry | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicondylitis