MedTrace Logo

Study of NV-101 for Safety and Efficacy in Pediatric Dental Patients Undergoing Procedures

NCT00309322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2006-11-17

No results posted yet for this study

Summary

This Phase 2 clinical study is designed as a multicenter, randomized, blinded, controlled study to evaluate the safety and efficacy of NV-101 in approximately 150 children 4 to 11 years of age. NV-101 or sham injection is administered at the completion of a dental procedure requiring local anesthesia with 2% lidocaine with 1:100,000 epinephrine. The dental procedure(s) shall be performed in a single quadrant of the mouth and include cavity preparation, restoration/filling, teeth cleaning (non-surgical scaling and/or root planing), or crowns.

Conditions

  • Anesthesia, Dental

Interventions

DRUG

Phentolamine Mesylate (NV-101)

Sponsors & Collaborators

  • Novalar Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mary Tavares, DDS · The Forsyth Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Completion
2006-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00309322 on ClinicalTrials.gov