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

Epicondylitis of the Elbow Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525043
• Other study ID #: SYN-EPI-2011
• Status: Completed
• Phase: Phase 4
• First received: January 30, 2012
• Last updated: March 4, 2014
• Start date: February 2012
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: International Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epicondylitis of the Elbow
• Tennis Elbow

Intervention

Drug:
• Naproxen
Naproxen 500mg BID for the first 2 weeks
• Synera patch twice daily
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
• Synera patch for 12hrs/day
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
• Naproxen
500mg bid
• Synera
Topical appication of single patch to elbow for 12hrs/day
• Synera
Single patch applied to elbow for 4hrs/twice daily

Locations

Country	Name	City	State
United States	International Clinical Research Institute	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
International Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily	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	Day 1 and Day 14
Secondary	Pain quality assessment scale	It is a vlaidated measure to assess the qulaity of scale	Every visit from the entry