Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points

The purpose of this pilot study is to explore the usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with myofascial trigger points. The study will consist of a 2-week, open-label treatment period followed by a 2 week follow-up period conducted at a single study site. Eligible patients must have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 identifiable myofascial trigger points. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population.

Inclusion criteria

• be at least 18 years of age
• have a clinical diagnosis of pain (minimum 1-month duration) associated with up to 3 myofascial trigger points
• have trigger points confined to the upper back, shoulder, and neck

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 topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
• have used any injected pain medication with 28 days preceding the Screening/Baseline Visit
• are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.