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

ZARS Pharma

Status and phase: Completed; Phase 2

Conditions: Shoulder Impingement Syndrome

Treatments: Drug: Heated lidocaine and tetracaine topical patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT01055444

SC-202

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Heated lidocaine/tetracaine topical patch

Experimental group

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.

Treatment:

Drug: Heated lidocaine and tetracaine topical patch