NCT01474382 is a Phase 4 clinical trial of OraVerse in Dental Anesthesia, sponsored by Novocol Pharmaceutical of Canada, Inc..

Who is sponsoring NCT01474382?

NCT01474382 is sponsored by Novocol Pharmaceutical of Canada, Inc..

What drugs are being tested in NCT01474382?

Interventions in NCT01474382: OraVerse, Sham injection.

What condition does NCT01474382 study?

NCT01474382 studies Dental Anesthesia, Anesthesia, Local, Anesthesia, Reversal.

Is NCT01474382 still recruiting?

NCT01474382 is currently completed. Last updated 28 August 2014.

Last reviewed 2014-08-28 · How we verify

NCT01474382

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 4, Multicenter, Randomized, Double-Blinded, Controlled Study of OraVerse® for Safety and Efficacy in Pediatric Dental Patients Undergoing Mandibular and Maxillary Procedures

Completed Phase 4 Last updated 28 August 2014

What this trial tests

Phase 4 trial testing OraVerse in Dental Anesthesia in 150 participants. Completed in 1 August 2014.

Timeline

1 February 2012

Primary endpoint
1 August 2014

1 August 2014

Quick facts

Lead sponsor	Novocol Pharmaceutical of Canada, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	150
Start date	1 February 2012
Primary completion	1 August 2014
Estimated completion	1 August 2014
Sites	7 locations across United States

Drugs / interventions tested

OraVerse — full drug profile →
Sham injection — full drug profile →

Conditions studied

Dental Anesthesia — all drugs for Dental Anesthesia →
Anesthesia, Local — all drugs for Anesthesia, Local →
Anesthesia, Reversal — all drugs for Anesthesia, Reversal →

Sponsor

Novocol Pharmaceutical of Canada, Inc. — full company profile →

Who can join

Adults 2 to 5, any sex, with Dental Anesthesia or Anesthesia, Local. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Incidence and severity of adverse events
Time frame: Up to 3 days
Clinically significant changes in vital signs
Time frame: Up to 3 days
Blood pressure and pulse
Clinically significant changes in oral cavity assessments
Time frame: Up to 3 days
Nerve injury
Time frame: Up to 3 days
Analgesics required for intraoral pain
Time frame: Up to 3 days

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of OraVerse

Trials testing the same drug.

NCT02995291 — Reversing the Effects of 0.5% Bupivacaine · Phase 4 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01474382 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novocol Pharmaceutical of Canada, Inc.
Last refreshed: 28 August 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01474382.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing