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

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.

Study Overview

• Status: Completed
• Conditions: Epicondylitis of the Elbow
• Intervention / Treatment: Drug: Naproxen; Drug: Naproxen; Drug: Synera patch for 12hrs/day; Drug: Synera; Drug: Synera; Drug: Synera patch twice daily

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • International Clinical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Naproxen	Drug: Naproxen; Naproxen 500mg BID for the first 2 weeks; Drug: Naproxen; 500mg bid
Experimental: Synera single patch applied for 12 hrs/day	Drug: Synera patch for 12hrs/day; 1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks; Drug: Synera; Topical appication of single patch to elbow for 12hrs/day; Drug: Synera; Single patch applied to elbow for 4hrs/twice daily
Experimental: Synera sinlgle patch applied for 4hrs twice daily	Drug: Synera; Topical appication of single patch to elbow for 12hrs/day; Drug: Synera; Single patch applied to elbow for 4hrs/twice daily; Drug: Synera patch twice daily; 1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain quality assessment scale	It is a vlaidated measure to assess the qulaity of scale	Every visit from the entry

Collaborators and Investigators

• Sponsor: International Clinical Research Institute
• Investigators: Principal Investigator: Srinivas Nalamachu, MD, International Clinical Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: January 31, 2012
• First Posted (Estimate): February 2, 2012

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Epicondylitis
• Additional Relevant MeSH Terms: Wounds and Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendon Injuries; Tendinopathy; Arm Injuries; Elbow Tendinopathy; Tennis Elbow; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: SYN-EPI-2011