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Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients

NCT01474382 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-08-29

No results posted yet for this study

Summary

The purpose of this study is to determine whether OraVerse is safe and effective for the reversal of dental anesthesia in children 2 to 5 years of age weighing at least 10 kg.

Conditions

  • Dental Anesthesia
  • Anesthesia, Local
  • Anesthesia, Reversal

Interventions

DRUG

OraVerse

1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight

OTHER

Sham injection

No drug administered, simulation of injection used in same manner as drug

Sponsors & Collaborators

  • Novocol Pharmaceutical of Canada, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Moore, DMD,PhD,MPH · University of Pittsburgh School of Dental Medicine

  • Elliot Hersh, DMD,MS,PhD · University of Pennsylvania

  • Joel Berg, DDS,MS · Seattle Children's Hospital

  • Judith Chin, DDS,MS · Indiana University

  • Brent Lin, DMD · University of California, San Francisco

  • Paul Casamassimo, MS,DDS · Nationwide Children's Hospital

  • Adam Marberger, DDS · Jean Brown Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2014-08-31
Completion
2014-08-31

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 NCT01474382 on ClinicalTrials.gov