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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Clinical Research Institute
ClinicalTrials.gov Identifier:
NCT01525043
First received: January 30, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by International Clinical Research Institute:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Pain quality assessment scale [ Time Frame: Every visit from the entry ] [ Designated as safety issue: No ]
    It is a vlaidated measure to assess the qulaity of scale


Enrollment: 78
Study Start Date: February 2012
Study Completion Date: September 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: International Clinical Research Institute
ClinicalTrials.gov Identifier: NCT01525043     History of Changes
Other Study ID Numbers: SYN-EPI-2011
Study First Received: January 30, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by International Clinical Research Institute:
Epicondylitis

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

ClinicalTrials.gov processed this record on April 17, 2014