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

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ClinicalTrials.gov Identifier: NCT01525043
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : March 5, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Epicondylitis of the Elbow Drug: Naproxen Drug: Synera patch twice daily Drug: Synera patch for 12hrs/day Drug: Synera Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2012
Primary Completion Date : February 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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
Experimental: Synera sinlgle patch applied 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
Drug: Synera
Single patch applied to elbow for 4hrs/twice daily


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily [ Time Frame: 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 :
  1. Pain quality assessment scale [ Time Frame: Every visit from the entry ]
    It is a vlaidated measure to assess the qulaity of scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01525043


Locations
United States, Kansas
International Clinical Research Institute
Overland Park, Kansas, United States, 66210
Sponsors and Collaborators
International Clinical Research Institute
Investigators
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute, Inc.
More Information

Responsible Party: International Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01525043     History of Changes
Other Study ID Numbers: SYN-EPI-2011
First Posted: February 2, 2012    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

Keywords provided by International Clinical Research Institute:
Epicondylitis

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action