Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome

March 14, 2012 updated by: ZARS Pharma Inc.

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg/tetracaine 70 mg topical patch for the treatment of pain associated with shoulder impingement syndrome

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this single center, 2-week open-label 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 shoulder impingement syndrome. 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

  • United States
    • Idaho
      • Boise, Idaho, United States, 83713
        • Injury Care Medical Center

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:

  • Pain associated with shoulder impingement syndrome in a single shoulder
  • Have tenderness at the attachment site of the rotator cuff tendons in the affected shoulder
  • Have positive Hawkins and Neers signs

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 injected pain medication within 14 days preceding the Screening/Baseline visit
  • Are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
  • Have a history of and/or past diagnosis of severe hepatic disease

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 topical patch
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
Drug: Heated lidocaine and tetracaine topical patch
Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch to the affected shoulder every 12 hours starting on the evening of Day 1 through the morning of Day 14 (morning and evening applications) and to remove the patch after 2-4 hours.
Other Names:
  • Synera

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 (general, normal work, and sleep)
Time Frame: Two weeks
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZARS Pharma Inc.

Investigators

  • Principal Investigator: Richard Radnovich, DO

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

March 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 22, 2010

First Posted (Estimate)

January 25, 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

Other Study ID Numbers

  • SC-202

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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