Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Status: | Completed |
---|---|
Conditions: | Orthopedic |
Therapuetic Areas: | Orthopedics / Podiatry |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 10/14/2017 |
Start Date: | February 2012 |
End Date: | September 2013 |
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
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.
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
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
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.
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