Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy

Study Overview
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Brief Summary
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The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.

Detailed Description
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The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.

Official Title
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An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Patellar Tendinopathy

Conditions
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Patellar Tendinopathy

Intervention / Treatment
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* Drug: Heated Lidocaine and Tetracaine Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 years of age have pain associated with patellar tendinopathy in a single knee (minimum 2-week duration) have tenderness at the proximal insertion of the patellar tendon in the affected knee Exclusion Criteria: have any history of surgery in the target knee have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit have had any injected steroids in the target knee within 3 months of the Screening/Baseline Visit have used any injected pain medication within 14 days preceding the Screening/Baseline Visit are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.) Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heated Lidocaine and Tetracaine Patch<br> | Drug: Heated Lidocaine and Tetracaine Patch<br>* Patients will apply one lidocaine 70 mg and tetracaine 70 mg topical patch to the affected knee twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours).<br>* Other names: Synera;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Victorian Institute of Sport Assessment (VISA) score | VISA questionnaire, an index of severity and symptoms of patellar tendinopathy, completed by the patient (beginning and end of the study). | Two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | Two weeks | 
| Patient Global Assessment of Treatment Satisfaction (PGAS) |  | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patellar tendonitis