Study Evaluating Heated Lidocaine/Tetracaine Topical Patch in Treatment of Patients With Shoulder Impingement Syndrome
An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome
1 other identifier
interventional
20
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedMarch 16, 2012
March 1, 2012
5 months
January 21, 2010
March 14, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Pain intensity
Two weeks
Secondary Outcomes (1)
Pain interference with activities (general, normal work, and sleep)
Two weeks
Study Arms (1)
Heated lidocaine/tetracaine topical patch
EXPERIMENTALPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZARS Pharma Inc.lead
Study Sites (1)
Injury Care Medical Center
Boise, Idaho, 83713, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Radnovich, DO
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
January 21, 2010
First Posted
January 25, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2010
Study Completion
September 1, 2010
Last Updated
March 16, 2012
Record last verified: 2012-03