- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01106989
Study Evaluating Heated Lidocaine/Tetracaine Patch in Patients With Pain Associated With Myofascial Trigger Points
March 14, 2012 updated by: ZARS Pharma Inc.
An Open-label Pilot Study Evaluating Synera® in the Treatment of Patients With Pain Associated With Myofascial Trigger Points
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heated lidocaine/tetracaine patch
Active
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain intensity
Time Frame: Two weeks
|
Two weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain interference with activities (eg, general, normal work, sleep)
Time Frame: Two weeks
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
April 16, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (Estimate)
April 20, 2010
Study Record Updates
Last Update Posted (Estimate)
March 16, 2012
Last Update Submitted That Met QC Criteria
March 14, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Muscular Diseases
- Neuromuscular Diseases
- Fibromyalgia
- Myofascial Pain Syndromes
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Tetracaine
Other Study ID Numbers
- SC-203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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