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

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

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.

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.

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.