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

NCT ID: NCT00889642

Last Updated: 2009-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Contains Lidocaine and Epinephrine

Group Type: ACTIVE_COMPARATOR

Iontophoretic Drug Delivery System with Lidocaine/Epinephrine

Intervention Type: DEVICE

Active- 10.5% Lidocaine/0.179% Epinephrine

Placebo

Contains Epinephrine

Group Type: PLACEBO_COMPARATOR

Iontophoretic Drug Delivery System with Epinephrine

Intervention Type: DEVICE

Placebo- 0.179% Epinephrine

Interventions

Iontophoretic Drug Delivery System with Lidocaine/Epinephrine

Active- 10.5% Lidocaine/0.179% Epinephrine

Intervention Type: DEVICE

Iontophoretic Drug Delivery System with Epinephrine

Placebo- 0.179% Epinephrine

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dharma Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Dharma Therapeutics Inc.

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Vince & Associates Clinical Research

Overland Park, Missouri, United States

Countries

United States

Other Identifiers

Dharma-NSCO3

Identifier Type: -

Identifier Source: org_study_id