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

Phase 4

Completed

• Conditions: Epicondylitis of the Elbow
• Interventions: Drug: Synera patch for 12hrs/day; Drug: Synera patch twice daily; Drug: Naproxen; Drug: Synera

• Registration Number: NCT01525043
• Lead Sponsor: International Clinical Research Institute

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 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

Study Timeline

• Study First Submitted: 2012-01-30
• Study First Submitted QC: 2012-01-31
• Study Start: 2012-02
• Study First Posted: 2012-02-02
• Primary Completion: 2013-02
• Study Completion: 2013-09
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-04
• Last Update Posted: 2014-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synera single patch applied for 12 hrs/day	Synera patch for 12hrs/day	-
Synera sinlgle patch applied for 4hrs twice daily	Synera patch twice daily	-
Naproxen	Naproxen	-
Synera single patch applied for 12 hrs/day	Synera	-
Synera sinlgle patch applied for 4hrs twice daily	Synera	-

Primary Outcome Measures

Name	Time	Method
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily	Day 1 and Day 14	Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily by the subject and the answer for question 5 is the basis for primary end poit

Secondary Outcome Measures

Name	Time	Method
Pain quality assessment scale	Every visit from the entry	It is a vlaidated measure to assess the qulaity of scale

Trial Locations

Locations (1)

International Clinical Research Institute; 🇺🇸 Overland Park, Kansas, United States