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Dose-Ranging Study of Intranasal Kovacaine Mist in Pediatric Subjects

NCT01701505 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-08-30

Study results available
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Summary

The purpose of this study is to assess the efficacy and safety of intranasally administered Kovacaine Mist for anesthetizing maxillary teeth in pediatric subjects.

Conditions

  • Anesthesia

Interventions

DRUG

400uL of Kovacaine Mist

2 unilateral intranasal sprays of 200uL each.

DRUG

200uL of Kovacaine Mist

2 unilateral intranasal sprays of 100uL each.

DRUG

120uL of Kovacaine Mist

2 unilateral intranasal sprays of 60uL each.

Sponsors & Collaborators

  • Triligent International

    collaborator INDUSTRY

  • Rho, Inc.

    collaborator INDUSTRY

  • St. Renatus, LLC

    lead INDUSTRY

Principal Investigators

  • Paul A. Moore, DMD/PhD/MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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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 NCT01701505 on ClinicalTrials.gov