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Validating a New Non-invasive Approach to Testing Lidocaine Effectiveness

NCT03680885 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-15

No results posted yet for this study

Summary

This work will assess the reliability of a simple painless test for the effectiveness of the commonly used local anesthetic lidocaine

Conditions

  • ADHD
  • Controls

Interventions

DRUG

Lidocaine gel

Lidocaine gel 5%, PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

DRUG

Placebo

PEG with FD\&C Blue No.1 (Brilliant Blue FCF)

DRUG

Injected lidocaine

Standard FDA-approved dental injectable lidocaine

Sponsors & Collaborators

  • Jacobi Medical Center

    collaborator OTHER

  • PhenoSolve, LLC

    lead INDUSTRY

Principal Investigators

  • Michael Segal, MD PhD · PhenoSolve, LLC

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2020-03-30
Completion
2020-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03680885 on ClinicalTrials.gov