Status:
COMPLETED
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Lead Sponsor:
International Clinical Research Institute
Conditions:
Epicondylitis of the Elbow
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT01525043
Start Date
February 1 2012
End Date
September 1 2013
Last Update
March 5 2014
Active Locations (1)
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1
International Clinical Research Institute
Overland Park, Kansas, United States, 66210