A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: V930

• Registration Number: NCT00721461
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2008-07-22
• Study First Submitted QC: 2008-07-23
• Study First Posted: 2008-07-24
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-03
• Last Update Posted: 2015-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Must be between the ages of 18 and 35
• Woman who are able to become pregnant must use an acceptable form of birth control

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Exclusion Criteria

• You are breast feeding
• You have taken any type of pain reliever within 12 hours of electrostimulation
• You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
• You have muscle atrophy, weakness or neuromuscular disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	V930	V930

Primary Outcome Measures

Name	Time	Method
Assess the tolerability of the MedPulser DDS device.	Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.