Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

The purpose of this single center, 2-week open-label 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 shoulder impingement syndrome. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Inclusion Criteria:

• Pain associated with shoulder impingement syndrome in a single shoulder
• Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
• Have positive Hawkins and Neers signs

Exclusion Criteria:

• Have used any topically applied pain medication on the target treatment area within 3 days preceding 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.)
• Have a history of and/or past diagnosis of severe hepatic disease

Other protocol-defined inclusion/exclusion criteria may apply