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

NCT ID: NCT01055444

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-09-30

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.

Conditions

Shoulder Impingement Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Heated lidocaine/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.

Group Type: EXPERIMENTAL

Heated lidocaine and tetracaine topical patch

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Synera

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZARS Pharma Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Radnovich, DO

Role: PRINCIPAL_INVESTIGATOR

Locations

Injury Care Medical Center

Boise, Idaho, United States

Countries

United States

Other Identifiers

SC-202

Identifier Type: -

Identifier Source: org_study_id