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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01106989
First received: April 16, 2010
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Myofascial Pain Syndromes
Drug: Heated lidocaine/tetracaine patch
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by ZARS Pharma Inc.:

Primary Outcome Measures:
  • Pain intensity [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain interference with activities (eg, general, normal work, sleep) [ Time Frame: Two weeks ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: ZARS Pharma Inc.
ClinicalTrials.gov Identifier: NCT01106989     History of Changes
Other Study ID Numbers: SC-203
Study First Received: April 16, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 28, 2014