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.

• Heated lidocaine/tetracaine patch (Drug), also known as Synera: Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch directly to each trigger point identified at the Screening/Baseline Visit (up to 3 trigger points). Patches will be administered for 4 hours, 2 times per day (total of 8 hours for each trigger point per day).

Primary outcomes

• Pain intensity [Two weeks]

Secondary outcomes

• Pain interference with activities (eg, general, normal work, sleep) [Two weeks]

Sex: All, ages: 18 Years to any

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.

• Richard L Rauck, MD, Principal investigator, The Center for Clinical Research