Back to resultsStudy Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points
Primary Purpose
Myofascial Pain Syndromes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heated lidocaine/tetracaine patch
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain Syndromes
Eligibility Criteria
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.
Sites / Locations
- The Center for Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heated lidocaine/tetracaine patch
Arm Description
Active
Outcomes
Primary Outcome Measures
Pain intensity
Secondary Outcome Measures
Pain interference with activities (eg, general, normal work, sleep)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01106989
Brief Title
Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points
Official Title
An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heated lidocaine/tetracaine patch
Arm Type
Experimental
Arm Description
Active
Intervention Type
Drug
Intervention Name(s)
Heated lidocaine/tetracaine patch
Other Intervention Name(s)
Synera
Intervention Description
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 Outcome Measure Information:
Title
Pain intensity
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Pain interference with activities (eg, general, normal work, sleep)
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Rauck, MD
Organizational Affiliation
The Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points
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