Safety and Efficacy Study of an Iontophoretic Patch Containing Lidocaine and Epinephrine for Venipuncture in Healthy Adult Volunteers

A Multicenter Double-Blind Randomized Placebo Controlled Two-Arm Study Evaluating the Safety and Efficacy of the Iontophoretic Administration of Lidocaine and Epinephrine Using Lidocaine Iontophoretic Drug Delivery System (IDDS) to Provide Local Anesthesia for Venipuncture in Healthy Adult Volunteer Subjects

The purpose of this study is to evaluate the effectiveness of administering Lidocaine and Epinephrine using an iontophoretic device treatment to provide local anesthesia to healthy adult volunteer subjects undergoing venipuncture.

Study Overview

• Status: Completed
• Conditions: Local Anesthesia
• Intervention / Treatment: Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine; Device: Iontophoretic Drug Delivery System with Epinephrine

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Missouri
    • Overland Park, Missouri, United States, 66212
      • Vince & Associates Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects may be of any race, either sex, and must be >18 years of age
• Healthy subjects as per medical screening
• Subjects must have intact, healthy skin (no tattoos, surgical scars, skin infections, etc.) where the iontophoresis treatment will be performed
• Subjects must be alert, oriented, mentally competent, and able to understand and comply with the requirements of the study
• Subjects must have signed and dated a written informed consent
• Female subjects of childbearing potential must have a negative pregnancy test result prior to the iontophoresis treatment

Exclusion Criteria:

• Subjects with a known allergy or sensitivity to lidocaine, epinephrine or other local anesthetics of the amide or ester type
• Subjects with a know sensitivity to any components (e.g. adhesives) of the IDDSSubjects who have undergone venipuncture in the treatment area within the prior 2 weeks or longer if bruising or hematoma is apparent
• Subjects who have taken an analgesic pain medication during the 24-hour period prior to the venipuncture in the posterior surface of the hand
• Subjects with skin allergies or have skin diseases (e.g. psoriasis, eczema
• Subjects with an open skin lesion at the treatment site
• Subjects who are pregnant or breastfeeding
• Subjects exposed to an investigational drug or device within the past 30 days or are involved concurrently in other treatment clinical trials
• Subjects who participated in previous DTI/Transcu clinical studies related to this product
• Subjects with known concurrent illness
• Subjects with "current" known/admitted substance abuse (alcohol/drug)
• Subjects with pacemakers and/or externally mounted electronic devices
• Current or history of conditions that contraindicate use of iontophoretic treatment or venipuncture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active; Contains Lidocaine and Epinephrine	Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine; Active- 10.5% Lidocaine/0.179% Epinephrine
PLACEBO_COMPARATOR: Placebo; Contains Epinephrine	Device: Iontophoretic Drug Delivery System with Epinephrine; Placebo- 0.179% Epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Following the iontophoresis treatment an IV will be inserted into the treatment area and the amount of pain will be assessed using the median visual analog pain scale (VAS).	4 hours
Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment.	4 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Determining the duration of anesthesia through standard pin prick testing.	4 hours

Collaborators and Investigators

• Sponsor: Dharma Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): June 1, 2009

Study Registration Dates

• First Submitted: April 27, 2009
• First Submitted That Met QC Criteria: April 28, 2009
• First Posted (ESTIMATE): April 29, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 23, 2009
• Last Update Submitted That Met QC Criteria: June 22, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate
• Other Study ID Numbers: Dharma-NSCO3