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

NCT01106989 | Completed Phase 2

• 1 other identifier: SC-203
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndromes

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  Two weeks

Secondary Outcomes (1)

• Pain interference with activities (eg, general, normal work, sleep)

  Two weeks

Study Arms (1)

Heated lidocaine/tetracaine patch

EXPERIMENTAL

Active

Drug: Heated lidocaine/tetracaine patch

Interventions

Heated lidocaine/tetracaine patch DRUG

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

Heated lidocaine/tetracaine patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• ZARS Pharma Inc.: lead

Study Sites (1)

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Richard L Rauck, MD

  The Center for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 20, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: March 16, 2012

Record last verified: 2012-03

Locations

US (1)