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

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ClinicalTrials.gov Identifier: NCT01106989
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : March 16, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myofascial Pain Syndromes Drug: Heated lidocaine/tetracaine patch Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Heated lidocaine/tetracaine patch
Active
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).
Other Name: Synera



Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Two weeks ]

Secondary Outcome Measures :
  1. Pain interference with activities (eg, general, normal work, sleep) [ Time Frame: Two weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01106989


Locations
United States, North Carolina
The Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
ZARS Pharma Inc.
Investigators
Principal Investigator: Richard L Rauck, MD The Center for Clinical Research

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01106989     History of Changes
Other Study ID Numbers: SC-203
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action