NCT01145326

Brief Summary

The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

June 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
4.5 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

June 14, 2010

Last Update Submit

March 14, 2017

Conditions

Pain PerceptionPhlebotomy

Keywords

venipuncturephlebotomypain perception

Outcome Measures

Primary Outcomes (1)

  • Venipuncture pain levels

    1 hour

Secondary Outcomes (1)

  • Undesirable side effects

    1 day

Study Arms (2)

Control

SHAM COMPARATOR

Sham-Functional microneedles (no actual microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Drug: 4% lidocaine gel application with sham microneedle device

Microneedle

EXPERIMENTAL

Functional microarray (FMA) (microneedles) application, prior to 4% lidocaine gel (LG4) placement.

Drug: Microneedle-facilitated lidocaine application

Interventions

4% lidocaine gel application with sham microneedle deviceDRUG

Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).

Also known as: 4% Lidocaine gel with sham-functional microarray (FMA)
Control
Microneedle-facilitated lidocaine applicationDRUG

Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device

Also known as: 4% lidocaine gel with functional microarray
Microneedle

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Schusterman Clinic

Tulsa, Oklahoma, 74135, United States

Location

Study Officials

  • Stephen H. Thomas, MD MPH

    University of Oklahoma

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 16, 2010

Study Start

January 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 16, 2017

Record last verified: 2017-03

Locations

US(1)