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

NCT00889642 | Completed Phase 2

• 1 other identifier: Dharma-NSCO3
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Local Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Determining the duration of anesthesia through standard pin prick testing.

  4 hours

Study Arms (2)

Active

ACTIVE COMPARATOR

Contains Lidocaine and Epinephrine

Device: Iontophoretic Drug Delivery System with Lidocaine/Epinephrine

Placebo

PLACEBO COMPARATOR

Contains Epinephrine

Device: Iontophoretic Drug Delivery System with Epinephrine

Interventions

Iontophoretic Drug Delivery System with Lidocaine/Epinephrine DEVICE

Active- 10.5% Lidocaine/0.179% Epinephrine

Active

Iontophoretic Drug Delivery System with Epinephrine DEVICE

Placebo- 0.179% Epinephrine

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dharma Therapeutics Inc.: lead

Study Sites (2)

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

Vince & Associates Clinical Research

Overland Park, Missouri, 66212, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 23, 2009

Record last verified: 2009-06

Locations

US (2)