CompletedPhase 4

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

United States78 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline recorded at 2 week visit for the question #5 of Brief Pain Inventory (BPI )Scale ® recorded before going to sleep daily

Timeframe: Day 1 and Day 14

Trial details

NCT IDNCT01525043

SponsorInternational Clinical Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-02

View on ClinicalTrials.gov More Epicondylitis of the Elbow trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.