Overview

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

Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
ZARS Pharma Inc.
Treatments:
Lidocaine
Tetracaine
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