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.
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: 1. 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 2. Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow 3. Naproxen Sodium: 500mg bid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Naproxen 500mg BID for the first 2 weeks
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
International Clinical Research Institute
Overland Park, Kansas, United States
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
Time frame: Day 1 and Day 14
Pain quality assessment scale
It is a vlaidated measure to assess the qulaity of scale
Time frame: Every visit from the entry
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500mg bid
Topical appication of single patch to elbow for 12hrs/day
Single patch applied to elbow for 4hrs/twice daily