International Clinical Research Institute
Overland Park, Kansas, 66210, United States
NCT Number: NCT01525043
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Overland Park, Kansas, 66210, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Topical appication of single patch to elbow for 12hrs/day
Time frame: Day 1 and Day 14
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: Every visit from the entry
It is a vlaidated measure to assess the qulaity of scale
International Clinical Research Institute
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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