Back to resultsStudy Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Heated lidocaine and tetracaine topical patch
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome
Eligibility Criteria
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
Sites / Locations
- Injury Care Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heated lidocaine/tetracaine topical patch
Arm Description
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.
Outcomes
Primary Outcome Measures
Pain intensity
Secondary Outcome Measures
Pain interference with activities (general, normal work, and sleep)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01055444
Brief Title
Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
Official Title
An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZARS Pharma Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heated lidocaine/tetracaine topical patch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Heated lidocaine and tetracaine topical patch
Other Intervention Name(s)
Synera
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain intensity
Time Frame
Two weeks
Secondary Outcome Measure Information:
Title
Pain interference with activities (general, normal work, and sleep)
Time Frame
Two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Radnovich, DO
Official's Role
Principal Investigator
Facility Information:
Facility Name
Injury Care Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
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