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

Myofascial Pain Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106989
• Other study ID #: SC-203
• Status: Completed
• Phase: Phase 2
• First received: April 16, 2010
• Last updated: March 14, 2012
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Heated lidocaine/tetracaine patch
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).

Locations

Country	Name	City	State
United States	The Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity		Two weeks	Yes
Secondary	Pain interference with activities (eg, general, normal work, sleep)		Two weeks	Yes