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

Shoulder Impingement Syndrome Clinical Trial

Official title:

An Open-Label Pilot Study Evaluating Synera® in the Treatment of Patients With Shoulder Impingement Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055444
• Other study ID #: SC-202
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2010
• Last updated: March 14, 2012
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Injury Care Medical Center	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity		Two weeks	Yes
Secondary	Pain interference with activities (general, normal work, and sleep)		Two weeks	Yes