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

Primary Purpose

Epicondylitis of the Elbow

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naproxen
Synera patch twice daily
Synera patch for 12hrs/day
Naproxen
Synera
Synera
Sponsored by
International Clinical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epicondylitis of the Elbow focused on measuring Epicondylitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • International Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Naproxen

Synera single patch applied for 12 hrs/day

Synera sinlgle patch applied for 4hrs twice daily

Arm Description

Outcomes

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
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
It is a vlaidated measure to assess the qulaity of scale

Full Information

First Posted
January 30, 2012
Last Updated
March 4, 2014
Sponsor
International Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01525043
Brief Title
Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Clinical Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.
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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis of the Elbow
Keywords
Epicondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Naproxen
Arm Type
Active Comparator
Arm Title
Synera single patch applied for 12 hrs/day
Arm Type
Experimental
Arm Title
Synera sinlgle patch applied for 4hrs twice daily
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Naproxen 500mg BID for the first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Synera patch twice daily
Intervention Description
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Synera patch for 12hrs/day
Intervention Description
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
500mg bid
Intervention Type
Drug
Intervention Name(s)
Synera
Intervention Description
Topical appication of single patch to elbow for 12hrs/day
Intervention Type
Drug
Intervention Name(s)
Synera
Intervention Description
Single patch applied to elbow for 4hrs/twice daily
Primary Outcome Measure Information:
Title
Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily
Description
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
Time Frame
Day 1 and Day 14
Secondary Outcome Measure Information:
Title
Pain quality assessment scale
Description
It is a vlaidated measure to assess the qulaity of scale
Time Frame
Every visit from the entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivas Nalamachu, MD
Organizational Affiliation
International Clinical Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Clinical Research Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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