Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: International Clinical Research Institute
• Treatments: Naproxen

Criteria

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.