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

This study has been completed.
Sponsor:
Information provided by:
Dharma Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00889642
First received: April 27, 2009
Last updated: June 22, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Local Anesthesia
Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine
Device: Iontophoretic Drug Delivery System with Epinephrine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dharma Therapeutics Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
  • Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determining the duration of anesthesia through standard pin prick testing. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: May 2009
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889642

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Missouri
Vince & Associates Clinical Research
Overland Park, Missouri, United States, 66212
Sponsors and Collaborators
Dharma Therapeutics Inc.
  More Information

No publications provided

Responsible Party: Ron Berenson, Acting Medical Director, Dharma Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00889642     History of Changes
Other Study ID Numbers: Dharma-NSCO3
Study First Received: April 27, 2009
Last Updated: June 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Lidocaine
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sensory System Agents
Sodium Channel Blockers
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 21, 2014