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

Phase 2

Completed

• Conditions: Shoulder Impingement Syndrome
• Interventions: Drug: Heated lidocaine and tetracaine topical patch

• Registration Number: NCT01055444
• Lead Sponsor: ZARS Pharma Inc.

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.

Study Timeline

• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Study Start: 2010-03
• Primary Completion: 2010-08
• Study Completion: 2010-09
• Status Verified: 2012-03
• Disposition First Submitted: 2012-03-14
• Disposition First Submitted QC: 2012-03-14
• Last Update Submitted: 2012-03-14
• Disposition First Posted: 2012-03-16
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heated lidocaine/tetracaine topical patch	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.

Primary Outcome Measures

Name	Time	Method
Pain intensity	Two weeks

Secondary Outcome Measures

Name	Time	Method
Pain interference with activities (general, normal work, and sleep)	Two weeks

Trial Locations

Locations (1)

Injury Care Medical Center; 🇺🇸 Boise, Idaho, United States