Evaluate the Depth and Duration of Anesthesia

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Two-Period, Crossover Study to Evaluate the Depth and Duration of Anesthesia of Synera™ Patches Compared to Placebo Patches Applied to Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891163
• Other study ID #: EN3274-101
• Status: Completed
• Phase: Phase 4
• First received: April 29, 2009
• Last updated: April 30, 2009
• Start date: December 2006
• Est. completion date: April 2007

Study information

• Verified date: April 2009
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the depth (mm) of anesthesia provided by the Synera topical patch (using sensory depth and pain depth evaluations), and to determine the duration (minutes) of anesthesia provided by the Synera topical patch (using dermal sensory testing and thermal sensory testing evaluations), compared with a matching heated placebo patch.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Had no known significant diseases

• Normal 12-lead electrocardiogram

• Willing to refrain from using any local topical preparations

Exclusion Criteria:

• Taken over-the-counter (OTC) or prescription analgesics in any form within 24 hours

• Known allergy or sensitivity to any component of the Synera patch, including lidocaine, sympathomimetic amines, other local anesthetics of the amide type, epinephrine, or other patch components

• Had an active dermatological disease of any origin that may have interfered with their ability to participate

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Synera™ Topical Patch (70 mg lidocaine/70 mg tetracaine)
30 minute applicable on antecubital fossa
• Placebo Patch
placebo

Locations

Country	Name	City	State
United States	UCSD Medical Center, Thornton Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
ZARS Pharma Inc.	Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensory and pain depth measurements		0, 30, 60, 90, 120 and 150 minutes
Primary	Dermal and thermal sensory testing evaluations		0, 30, 60, 90, 120 and 150 minutes
Secondary	Assess the safety and tolerability of the Synera topical patch compared with a matching heated placebo patch		Throughout the study
Secondary	Evaluate local effects on the skin at the site of patch application for dermal adverse events (AEs)		Throughout the study