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

ZARS Pharma

Status and phase

Completed

Phase 2

Conditions

Myofascial Pain Syndromes

Treatments

Drug: Heated lidocaine/tetracaine patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT01106989

SC-203

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.