Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients 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.