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

An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points

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 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.