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

• Sponsor: Dharma Therapeutics Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00889642
• Collaborator: (none)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 45
• Patients Per Site Per Month: 44.2

Study Details

Study Description

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.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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]

2. Monitor the nature and frequency of adverse events associated with the iontophoretic device through observation during treatment. [4 hours]

Secondary Outcome Measures

1. Determining the duration of anesthesia through standard pin prick testing. [4 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Advanced Clinical Research Institute	Anaheim	California	United States	92801
2	Vince & Associates Clinical Research	Overland Park	Missouri	United States	66212

Sponsors and Collaborators

• Dharma Therapeutics Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00889642
• Other Study ID Numbers: Dharma-NSCO3
• First Posted: Apr 29, 2009
• Last Update Posted: Jun 23, 2009
• Last Verified: Jun 1, 2009

• Additional relevant MeSH terms: Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

No Results Posted as of Jun 23, 2009