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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):
International Clinical Research Institute

Tracking Information
First Submitted Date  ICMJE January 30, 2012
First Posted Date  ICMJE February 2, 2012
Last Update Posted Date March 5, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2012)
Pain quality assessment scale [ Time Frame: Every visit from the entry ]
It is a vlaidated measure to assess the qulaity of scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epicondylitis of the Elbow
Intervention  ICMJE
  • Drug: Naproxen
    Naproxen 500mg BID for the first 2 weeks
  • 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 patch for 12hrs/day
    1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
  • Drug: Naproxen
    500mg bid
  • Drug: Synera
    Topical appication of single patch to elbow for 12hrs/day
  • Drug: Synera
    Single patch applied to elbow for 4hrs/twice daily
Study Arms  ICMJE
  • Active Comparator: Naproxen
    Interventions:
    • Drug: Naproxen
    • Drug: Naproxen
  • Experimental: Synera single patch applied for 12 hrs/day
    Interventions:
    • Drug: Synera patch for 12hrs/day
    • Drug: Synera
  • Experimental: Synera sinlgle patch applied for 4hrs twice daily
    Interventions:
    • Drug: Synera patch twice daily
    • Drug: Synera
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2014)
78
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2012)
75
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01525043
Other Study ID Numbers  ICMJE SYN-EPI-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party International Clinical Research Institute
Study Sponsor  ICMJE International Clinical Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Srinivas Nalamachu, MD International Clinical Research Institute, Inc.
PRS Account International Clinical Research Institute
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP