NCT00721461

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2008

Completed
Last Updated

August 4, 2015

Status Verified

August 1, 2015

Enrollment Period

3 months

First QC Date

July 22, 2008

Last Update Submit

August 3, 2015

Conditions

Healthy

Keywords

AssessTolerabilityMedPulser DDS device

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

1

EXPERIMENTAL

V930

Biological: V930

Interventions

V930BIOLOGICAL

Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.

1

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2008

First Posted

July 24, 2008

Study Start

July 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

August 4, 2015

Record last verified: 2015-08