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

International Clinical Research Institute

Status and phase: Completed; Phase 4

Conditions: Epicondylitis of the Elbow

Treatments: Drug: Synera patch twice daily; Drug: Synera patch for 12hrs/day; Drug: Naproxen; Drug: Synera

Study type: Interventional

Funder types: Other

Identifiers

NCT01525043

SYN-EPI-2011

Details and patient eligibility

About

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.

Full 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 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

Enrollment: 78 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 3 patient groups

Naproxen

Active Comparator group

Treatment:

Drug: Naproxen

Drug: Naproxen

Synera single patch applied for 12 hrs/day

Experimental group

Treatment:

Drug: Synera

Drug: Synera patch for 12hrs/day

Drug: Synera

Synera sinlgle patch applied for 4hrs twice daily

Experimental group

Treatment:

Drug: Synera patch twice daily

Drug: Synera

Drug: Synera