Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis … (NCT01525043) | Clinical Trial Compass
CompletedPhase 4
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
United States78 participantsStarted 2012-02
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily