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OpenTrials
Completed

NCT Number: NCT01525043

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

International Clinical Research Institute

Overland Park, Kansas, 66210, United States

About this study

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:

  • 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
  • Synera patch ®: A single patch applied for 12 hours/day to the medial or lateral side of the index elbow
  • Naproxen Sodium: 500mg bid

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

Naproxen 500mg BID for the first 2 weeks

Synera patch twice daily

Drug

1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks

Synera patch for 12hrs/day

Drug

1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks

Synera

Drug

Topical appication of single patch to elbow for 12hrs/day

Primary outcomes

  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 outcomes

  1. Pain quality assessment scale

    Time frame: Every visit from the entry

    It is a vlaidated measure to assess the qulaity of scale

Sponsors and collaborators

Lead sponsor

International Clinical Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 2, 2012
Registry last updated
Mar 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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