Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow
NCT ID: NCT01525043
Last Updated: 2014-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
78 participants
INTERVENTIONAL
2012-02-29
2013-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Naproxen
Naproxen
Naproxen 500mg BID for the first 2 weeks
Naproxen
500mg bid
Synera single patch applied for 12 hrs/day
Synera patch for 12hrs/day
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
Synera
Topical appication of single patch to elbow for 12hrs/day
Synera sinlgle patch applied for 4hrs twice daily
Synera patch twice daily
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
Synera
Single patch applied to elbow for 4hrs/twice daily
Interventions
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Naproxen
Naproxen 500mg BID for the first 2 weeks
Synera patch twice daily
1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
Synera patch for 12hrs/day
1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
Naproxen
500mg bid
Synera
Topical appication of single patch to elbow for 12hrs/day
Synera
Single patch applied to elbow for 4hrs/twice daily
Eligibility Criteria
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Inclusion Criteria
* Age 18 or higher
* Minimum of 4 on Question 5 of BPI
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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International Clinical Research Institute
OTHER
Responsible Party
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Principal Investigators
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Srinivas Nalamachu, MD
Role: PRINCIPAL_INVESTIGATOR
International Clinical Research Institute, Inc.
Locations
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International Clinical Research Institute
Overland Park, Kansas, United States
Countries
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Other Identifiers
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SYN-EPI-2011
Identifier Type: -
Identifier Source: org_study_id
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