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

Phase 2

Completed

• Conditions: Myofascial Pain Syndromes
• Interventions: Drug: Heated lidocaine/tetracaine patch

• Registration Number: NCT01106989
• Lead Sponsor: ZARS Pharma Inc.

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-04-16
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heated lidocaine/tetracaine patch	Heated lidocaine/tetracaine patch	Active

Primary Outcome Measures

Name	Time	Method
Pain intensity	Two weeks

Secondary Outcome Measures

Name	Time	Method
Pain interference with activities (eg, general, normal work, sleep)	Two weeks

Trial Locations

Locations (1)

The Center for Clinical Research; 🇺🇸 Winston-Salem, North Carolina, United States