A Phase 2 interventional study of Heated lidocaine/tetracaine patch in Myofascial Pain Syndromes, sponsored by ZARS Pharma Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-16.
Sponsored by ZARS Pharma Inc. · Phase 2, Interventional, and Treatment
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.
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 20 is below the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →ZARS Pharma Inc. is the lead sponsor of 24 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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).
Also known as: Synera
Pain intensity
Time frame: Two weeks
Pain interference with activities (eg, general, normal work, sleep)
Time frame: Two weeks
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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ZARS Pharma Inc.