Evaluation of the Depth and Duration of Anesthesia From Heated Lidocaine/Tetracaine (Synera®) Patches Compared With 5% Lidocaine (Lidoderm®) Patches Applied to Healthy Adult Volunteers

January 2, 2013 updated by: CRI Lifetree
This will be a randomized, single-blind, active-controlled, two-period crossover study in adult volunteers to compare the duration and depth of anesthesia between Synera® and Lidoderm® patches when applied for 30 minutes and 4 hours. The study will include a Screening Visit, two Treatment Periods, and a Follow-Up Phone Contact.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  1. Subject is male or female 18-60 years of age, inclusive.
  2. Subject is judged by the Investigator to be in generally good health at screening based upon the results of a medical history, physical examination, clinical laboratory profile, and 12-lead electrocardiogram (ECG).
  3. Subject is willing to refrain from using any local topical preparations on the volar aspect of the forearms for 24 hours prior to each site visit.
  4. Subject has normal, intact skin bilaterally at the antecubital area.

  5. If female, must be of non-childbearing potential (defined as postmenopausal for at least 1 year or surgically sterile [bilateral tubal ligation, bilateral oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one of the following methods of birth control):

    • Total abstinence from sexual intercourse (minimum of one complete menstrual cycle before study entry),
    • A vasectomized partner,
    • Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to test product administration,
    • Intrauterine device (IUD), or
    • Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal jellies or cream).
  6. If female, must have a negative urine pregnancy test at Screening and at check-in of each Treatment Period.
  7. Subject is willing to be blindfolded during the study and agrees to abide by all study restrictions and comply with all study procedures.
  8. Able to fluently speak and understand English and be able to provide meaningful written informed consent for the study.

Exclusion:

  1. Subject has clinically significant ECG abnormalities at screening.
  2. Subject is currently receiving class I, II, or III anti-arrhythmic agents.
  3. Subject has used over-the-counter (OTC) or prescription analgesics within 24 hours prior to either study period.
  4. Subject has a known allergy or history of significant adverse reaction to any component of the treatment or related compounds.
  5. Subject has a history of or active use or abuse of illicit drug substance or alcohol abuse.
  6. Subject has a positive urine test result for drugs of abuse or a positive ethanol breath test at the Screening Visit or check-in to Treatment Visit 1.
  7. Subject has active dermatological disease of any origin that may interfere with the ability to participate.
  8. Subject has denuded or broken skin on either forearm.
  9. Subject has a history of unstable peripheral/vascular disease and/or hypertensive vascular disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Synera® for 30min & Lidoderm® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
Drug: Heated Lidocaine/Tetracaine Patch
Other Names:
  • Synera® Patch
Drug: 5% Lidocaine Patch
Other Names:
  • Lidoderm® Patch
Active Comparator: Lidoderm® for 30min & Synera® for 4 hours
Heated Lidocaine/Tetracaine (Synera®)applied to one forearm for either 30 minutes or 4 hours and a 5% Lidocaine (Lidoderm®) patch applied to the alternate forearm for the alternate time period.
Drug: Heated Lidocaine/Tetracaine Patch
Other Names:
  • Synera® Patch
Drug: 5% Lidocaine Patch
Other Names:
  • Lidoderm® Patch

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Depth of Anesthesia measured in mm via insertion of 21-gauge needle into the skin.
Time Frame: Approximately 5 months
Approximately 5 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Anesthesia measured in sensory presence, absence, and thermal thresholds.
Time Frame: Approximately 5 months
Approximately 5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CRI Lifetree

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nuvo Research Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Miroslav Backonja, MD, CRI Lifetree

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCR-07-01-101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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