NCT00889642

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Dharma Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	Iontophoretic Drug Delivery System with Lidocaine/Epinephrine	Active- 10.5% Lidocaine/0.179% Epinephrine
DEVICE	Iontophoretic Drug Delivery System with Epinephrine	Placebo- 0.179% Epinephrine

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-05-01
• Completion: 2009-06-01
• First posted: 2009-04-29
• Last updated: 2009-06-23

Locations

2 sites across 1 country: United States