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